Jobs
>
Scottsdale

    Quality engineering manager - Scottsdale, United States - West Pharmaceutical Services

    West Pharmaceutical Services
    West Pharmaceutical Services Scottsdale, United States

    3 weeks ago

    Default job background
    Description
    Requisition ID: 65935


    Date:
    May 16, 2024


    Location:
    Scottsdale, Arizona, US


    Department:
    Quality


    Description:

    Who We Are:


    Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

    At West, we are by the side of patients.

    The work we do impacts patients' lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health.

    We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges.

    We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect.

    With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020.

    We serve by the side of our community.

    Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.


    Job Summary:


    Responsible for managing and coordinating the site materials control process and the Quality Engineers, QA Supervisors, and other technical support functions, including the Metrology Lab, for the proper material controls management.

    Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational competence within area of responsibility.

    Will set strategic direction of these areas and define priorities for work to be performed based on business needs; as well as ensuring that these areas are partnering with operations to meet production and supply chain needs.

    Responsible for the implementation of continuous improvement projects to ensure product distribution is in compliance with applicable internal procedures, Quality Standards and regulatory requirements.

    Ensure the systems and products comply with applicable government regulations, as well as internal processes and procedures. This position will support a proper risk management process ensuring compliance and processes efficiency.


    Essential Duties and Responsibilities:
    Support site materials control activities and work cross functionally across different departments to ensure a proper materials control management.
    Accountable for the activities of the technical Quality Engineering functions at the Scottsdale Operations Center.
    Understand the needs of Operations and the business overall to set priorities for the Quality Engineering group reporting line.

    Create, define, and implement complex site strategies that supports a continuous improvement process through the entire material control process to ensure a proper containment process for non-conformant materials.

    Evaluate, design, implement and improve production and process control strategy to achieve quality management, plant objectives and a proper material control process.

    Create strategies to control costs, reduce risks and improve productivity.

    May create or review and approve documents such as investigations, work instructions, SOP's, device master record, qualifications and validation protocols and results, etc., as needed.

    Provide periodic updates on project management progress to upper management as planned and as part of the Goals and objectives defined.

    Provide effective quality engineering leadership in teamwork development, effective communication, and quick responses to customer needs.
    Build organization capability for quality engineering in the selection and mentoring of professionals.

    Build a strong interactive, working, and strategic relationship with design quality engineering manufacturing, R&D, corporate quality management, operations, supply chain and other staff.

    Assist and participate in audits as SME or by supporting audit's execution.
    Keep current with new technologies and cGMP regulations.
    Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, i.e., Lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving.

    Ensures a proper training and re-certification process is executed as appropriate for quality and other personnel in relation to improvements or direct reports.

    Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, etc.).
    Ensure that functions are properly resourced to meet goals and objectives of the business.
    Assure that direct reports have been adequately trained for their role.

    Recruit, train, develop, and lead staff to accomplish individual and organizational goals, adhere to policies/procedures and establish/maintain a 'culture of quality'.

    Assure that the Quality System is compliant with applicable Regulatory and Industry standards.
    Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.

    Generate, review, or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply, and quality agreement), verification of compliance, or for filings with regulatory bodies.

    Perform other tasks as assigned Assist in the execution Quality strategic plans and policies for Scottsdale site.
    Decisions are guided by policies, procedures, and business plan; receives guidance from the senior manager.


    Basic Qualifications:

    Education or Equivalent Experience:
    Engineering Bachelor's Degree or equivalent
    10+ years of experience in a Medical Device/GMP industry; with 5-10 years of People's management experience working with validations, pFMEA, Risk Management, Root Cause Methodology, CAPA, MSA, Lean Manufacturing, Six Sigma, Auditing process, Project Management

    Preferred Knowledge, Skills, and Abilities:
    Master's degree preferred with an emphasis in Engineering, Science, or Business.
    Six Sigma certified Black Belt preferred.
    Auditing process knowledge
    Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
    Ability to work effectively with teams and manage multiple tasks in order to meet tight deadlines.
    Effective functional and technical knowledge. Experience with effective use of Quality Tools (MSA, Capability, pFMEA, validations) as well as statistics and sampling plans
    Demonstrated people skills specific to team building, problem solving and conflict resolution.
    Knowledge of GMP requirements.
    Project management experience and ability to present project's progress to upper management.
    Excellent presentation, writing, verbal, computer, interpersonal and communication skills.
    Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
    Manages competing demands, makes timely and sound decisions, even under conditions of risk.
    Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding.

    Knowledge in Medical Device Regulatory Requirements and MD Standards: 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, GDP.

    CQA/CQE Certified is preferred.


    Travel Requirements:
    None


    Physical and Mental Requirements:
    Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.

    Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.

    May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity.

    If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.

    Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
    The ability to be able to lift and carry various items up to 50lbs.

    Medium – exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

    LI-KR1

    West is an equal opportunity employer and we value diversity at our company.

    We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

    If you have a special need that requires accommodation in order to apply to West, please send an email to Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

    #J-18808-Ljbffr
  • Venmo

    Engineering Manager

    4 days ago

    Venmo Scottsdale, United States Full time

    At PayPal (NASDAQ: PYPL), we believe that every person has the right to participate fully in the global economy. Our mission is to revolutionize commerce globally to make moving money, selling and shopping, personalized and secure. · Job Description Summary: · Venmo is looking f ...

  • NetApp

    Manager, Desktop Engineering

    3 weeks ago

    NetApp Scottsdale, United States

    Title: Manager, Desktop Engineering · Location: Research Triangle Park, NC, US, 27709 · Requisition ID: About NetApp · We're forward-thinking technology people with heart. We make our own rules, drive our own opportunities, and try to approach every challenge with fresh eyes. ...

  • CyberTec

    Release Manager/Engineer

    5 days ago

    CyberTec Scottsdale, United States

    Only USC/GC/GC-EAD · CVS Healthcare · Release Manager/Engineer · 100% Onsite in Scottsdale, AZ from day 1. · 6+ Month Contract · Phone then Video · $50-52/hr on C2C · Job Description: · The "Release Manager/Engineer" will play a vital role in continually enhancing the compa ...

  • Larson Engineering

    Structural Engineering Manager

    3 weeks ago

    Larson Engineering Scottsdale, United States

    Job Description · Job Description · Build your future on our foundation of excellence · Are you looking for a rewarding career opportunity that also gives you a stake in a company's performance as an employee-owner? Larson Engineering, Inc. has a long-standing record of success ...

  • CyberTec

    Release Manager/Engineer

    2 days ago

    CyberTec Scottsdale, United States

    Only USC/GC/GC-EAD · CVS Healthcare · Release Manager/Engineer · 100% Onsite in Scottsdale, AZ from day 1. · 6+ Month Contract · Phone then Video · $50-52/hr on C2C · Job Description: · The "Release Manager/Engineer" will play a vital role in continually enhancing the com ...

  • Granicus

    Software Engineering Manager

    1 week ago

    Granicus Scottsdale, United States

    The Company · Serving the People Who Serve the People · Granicus is driven by the excitement of building, implementing, and maintaining technology that is transforming the Govtech industry by bringing governments and their constituents together. We are on a mission to support our ...

  • Larson Engineering

    Civil Engineering Manager

    8 hours ago

    Larson Engineering Scottsdale, United States

    Build your future on our foundation of excellence · Are you looking for a rewarding career opportunity that also gives you a stake in a company's performance as an employee-owner? Larson Engineering, Inc. has a long-standing record of success since its establishment in 1979 and ...

  • Larson Engineering

    Structural Engineering Manager

    3 weeks ago

    Larson Engineering Scottsdale, United States

    Job Description · Job DescriptionBuild your future on our foundation of excellence · Are you looking for a rewarding career opportunity that also gives you a stake in a company's performance as an employee-owner? Larson Engineering, Inc. has a long-standing record of success sin ...

  • Axon

    Sr. Mechanical Engineering Manager

    2 weeks ago

    Axon Scottsdale, United States

    Join Axon and be a Force for Good.At Axon, we're on a mission to Protect Life. We're explorers, pursuing society's most critical safety and justice issues with our ecosystem of devices and cloud software. Like our products, we work better together. We connect with candor and care ...

  • Onsemi

    Senior Manager of Software Engineering, Data Integration

    2 weeks ago

    Onsemi Scottsdale, United States Full time

    Senior Manager of Software Engineering, Data Integration · Location: US (Scottsdale, AZ) · About the Role: · We are seeking a highly skilled and experienced software engineering leader to lead the design and development of our modern enterprise data integration platform. This ...

  • Paradigm Design

    Civil Engineer/Project Manager

    3 weeks ago

    Paradigm Design Scottsdale, United States

    Job Description · Job DescriptionSalary: · Company Overview · Paradigm Design is a leading national civil engineering firm specializing in land development and infrastructure civil engineering projects across various sectors including education, entertainment, retail, industrial ...

  • City of Scottsdale, AZ

    Traffic Engineering and Operations Manager

    1 week ago

    City of Scottsdale, AZ Scottsdale, United States

    Salary: $105, $152,692.80 AnnuallyLocation : Scottsdale, AZJob Type: Full-Time RegularJob Number: FY Division: PUBLIC WORKSDepartment: TRAFFIC ENGINEERINGOpening Date: 06/03/2024Closing Date: 6/17/2024 11:59 PM ArizonaIntroduction The Traffic Engineering and Operations Manager di ...

  • Axon

    NPI Engineering Program Manager

    2 weeks ago

    Axon Scottsdale, United States

    Your Impact · We have an aggressive schedule for development and release of next generation De-escalation Devices (aka TASER) products. The NPI group is driving changes to ensure that new products can be built at scale with high yield and low cost, and we need highly skilled, mot ...

  • City of Scottsdale, AZ

    Traffic Engineering and Operations Manager

    1 week ago

    City of Scottsdale, AZ Scottsdale, United States

    Salary: $105, $152,692.80 Annually · Location : Scottsdale, AZ · Job Type: Full-Time Regular · Job Number: FY · Division: PUBLIC WORKS · Department: TRAFFIC ENGINEERING · Opening Date: 06/03/2024 · Closing Date: 6/17/2024 11:59 PM Arizona · Introduction · The Traffic Engi ...

  • Axon

    Engineering Program Manager II

    2 weeks ago

    Axon Scottsdale, United States

    We are an equal opportunity employer that promotes justice, advances equity, values diversity and fosters inclusion. We're committed to hiring the best talent — regardless of race, creed, color, ancestry, religion, sex (including pregnancy), national origin, sexual orientation, a ...

  • Nesco Resource

    Engineering Manager

    4 days ago

    Nesco Resource Tempe, United States

    Engineering Manager - (Aerospace - Product Development/Design) · **Must be authorized to work in the U.S.** · International Trade Compliance Requirements (each point only if applicable): · To conform to U.S. export control regulations, the applicant should be eligible for any req ...

  • Bradley & Associates , Inc.

    Water Wastewater Engineer-Project Manager

    1 week ago

    Bradley & Associates , Inc. Scottsdale, United States

    National Engineering firm with a focus on water engineering and water/wastewater facility design is looking for a Civil PE Project Manager to ad to the Arizona team. The successful candidate will have experience with an emphasis on water/wastewater design projects for municipalit ...

  • PayPal

    Engineering Manager

    3 weeks ago

    PayPal Scottsdale, United States

    At PayPal (NASDAQ: PYPL), we believe that every person has the right to participate fully in the global economy. Our mission is to revolutionize commerce globally to make moving money, selling and shopping, personalized and secure. · Job Description Summary: · As a member of the ...

  • Renesas Electronics

    Product Engineering Manager

    3 weeks ago

    Renesas Electronics Tempe, United States

    Job Description: · At Renesas, the Product Engineer is responsible for NPI execution – you will be managing and working with our design, product & test development team in US, EU and APAC; supporting new product introduction projects & activities to ensure smooth transition of th ...

  • Honeywell

    Engineering Project Management

    3 weeks ago

    Honeywell Tempe, United States

    Responsibilities · - Identify opportunities to reduce Repair & Overhaul (R&O) cost through in-depth data analysis, opportunity identification and project implementation · - Actively manage efforts to increase R&O value proposition regarding Honeywell's aftermarket operations · ...