- Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard.
- Review and approve product / process deviations or rework documentation.
- Provide quality reports and review trending on assigned areas of responsibility.
- Work independently and with project teams to develop deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
- Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
- Meet company and departmental goals in the continuous improvement of all products, services and processes.
- Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer's experience.
- Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
- Maintain information and statistics on program's quality performance on a monthly basis.
- Perform DOEs (Design of Experiments) to help improve and optimize new and/or existing plant processes or job protocols.
- Complete auditor certification and perform internal ISO and quality systems audits in accordance with ISO standards including recommending ways to resolve any issues identified by the audits.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
- Education or
- Bachelor's in Science, Operations, or Business
- Experience: 3-5 years of experience
- Experience using Six Sigma & SPC tools and techniques
- Experience with drug handling and medical device regulations (21 CFR 210, 211, and 820)
- Experience with ISO 9000 and ISO 13485 standards and GMPs
- Excellent written and oral communication skills
- Excellent critical reading and writing skills
- Problem solving including root cause failure analysis methods
- Planning/organizational skills
- Negotiating
- Computer skills required especially MS office applications and statistical analysis systems
- General understanding of manufacturing and plant operations
- ASQ certification (CQE or CQA)
- Green or Black Belt certification
- Chemistry or Engineering Degree
- Graduate degree
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
- Must be able to travel up to 0% of the time
- 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.
- Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments. 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.
-
Medical Device
5 days ago
Elucent Medical, Inc. Phoenix, United StatesJob Title: · Clinical Sales Representative · Reports to: · Director of Sales · EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS · Bachelor's degree in a related field (e.g., life sciences, business, healthcare management). · 1-2 years of operating room and clinical medic ...
-
Medical Device Assembler
8 hours ago
Medtronic, plc Tempe, United StatesAs a Medical Device Assembler, you will perform a variety of tasks ranging from repetitive to non-repetitive production assembly in a cleanroom environment. Working under moderate supervision, you will assemble medical devices according to good manuf Medical, Assembler, Manufactu ...
-
Device Specialist II
8 hours ago
Impilo Phoenix, United StatesDevice Specialist II (Phoenix) · Hourly rate: Starts at $18 · Type: Full Time (40 Hrs + overtime if needed) · WHAT YOU'LL DO · Work on-site at our new Phoenix location as part of our Center of Excellence Support Team, partnering with our customers and effectively resolving issues ...
-
Medical Records Clerk II
8 hours ago
SMI IMAGING LLC Scottsdale, United States· GENERAL DESCRIPTION/POSITION GOAL: · I. JOB RELATED FUNCTIONS: Demonstrates competency in the performance of job related skills appropriate to his/her customer populations and departmental services. · Responsible for continuous follow ups on all types of inbound and outbound ...
-
Medical Device Assembler
1 week ago
Broadleaf Results Tempe, United StatesOverview: · Responsibilities include: · - Training and certification on Wafer Testing equipment, including: SPEA, J750 and LTX. · - Training and certification on Retention Bake Oven · - Post Wafer Test Inspection (scope work - using low and high power) · - Working in a team envir ...
-
Medical Device Assembler
2 weeks ago
Broadleaf Results Tempe, United StatesResponsibilities include: · - Training and certification on Wafer Testing equipment, including: SPEA, J750 and LTX. · - Training and certification on Retention Bake Oven · - Post Wafer Test Inspection (scope work - using low and high power) · - Working in a team environment · Req ...
-
Medical Device Sales Representative
5 days ago
Fortune 50 Hospital Medical Device-$150k plus Phoenix, United StatesTop Medical Sales Opportunity: Hospital Call Point, MRI, software · Fortune 50 Medical Sales Device Company- Game changing technology for hospitals. Call points are C-Suite, MRI, Hospital Managers. Capital equipment, disposables, software sells. This is a Territory Manager sales ...
-
Medical Device Assembler
2 weeks ago
Broadleaf Results Tempe, United StatesResponsibilities include: · - Training and certification on Wafer Testing equipment, including: SPEA, J750 and LTX. · - Training and certification on Retention Bake Oven · - Post Wafer Test Inspection (scope work - using low and high power) · - Working in a team environment · Req ...
-
IntePros Consulting Scottsdale, United StatesIntePros is currently looking for a · Quality Engineer, Medical Device Software development · to join one of our premier Medical Device manufacturer clients in Scottsdale, AZ. The · Quality Engineer · will provide quality leadership, governance, and engineering best practices ...
-
Medical Device Operator AZ
1 week ago
Total Presence Management phoenix, United StatesTotal Presence Management is seeking for a Level 1 - Medical Device Operator to join a World-Wide Medical Manufacturing company in Phoenix, Arizona. In this role, you will be working with the Manufacturing team and manufacturing medical devices. In order to qualify as a level 1, ...
-
Medical Device Sales Representative
1 day ago
Dinjob Phoenix, United States**The Career:** · Our client is a medical device manufacturer in the pediatric medical industry providing the very best care to patients. A growing organization with upwards mobility. This role is ideal for a B2B Sales Professional looking to break into medical device sales. The ...
-
Medical Records Clerk Ii
2 weeks ago
SimonMed Imaging MSO, LLC Scottsdale, United States**GENERAL DESCRIPTION/POSITION GOAL**: · **I. **_JOB RELATED FUNCTIONS:_** · - Demonstrates competency in the performance of job related skills appropriate to his/her customer populations and departmental services. · - Responsible for continuous follow ups on all types of inbound ...
-
Orthopaedic Medical Device Campus Instructor
1 week ago
Medical Sales College Phoenix, United StatesAs a Campus Instructor, you will be delivering both on-campus and online education of MSC programs as approved by the state's licensing requirements. In a coordinated effort with the Campus Director, you will ensure positive student experience, and from time to time develop emplo ...
-
Medical Assistant II
3 days ago
CleanSlate Centers Glendale, United States Full timeJob Details · Description · Qualifications · Why You Would Love This Job · You care. Along with a smile and warm conversation, you can make all the difference to our patients in recovery. As a Medical Assistant your work WILL make an impact every single day. Your attention ...
-
Assemblers (Medical Device) - Urgent Need
2 weeks ago
broadleaf Tempe, United States**Hiring Assemblers in Tempe** · **Pay: $18.00-$18.90/Hour base rate** · **Hours: 5:30 am - 5:30 pm (day shift)** · **5:30pm to 5:30am (Night shift)** · **Days: every Sunday, Monday, Tuesday and every other Wednesday (A Shift)** · **Days: Every other Wednesday, and every Thursday ...
-
Director, Medical Device Operations
3 days ago
West Pharmaceutical Services Phoenix, United StatesRequisition ID: Date: Jun 18, 2024- Location: Phoenix, Arizona, US- Department: Operations- 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 op ...
-
Medical Lab Technician II
1 day ago
Phoenix Children's Phoenix, United States Full timePosition Summary Phoenix Childrenâ€s is recruiting for Medical Lab Technician/Scientists to join our Microbiology, Blood Bank, and Core Lab teams at the Thomas Main Lab located in downtown Phoenix. $3000 sign on bonus is offered. Full-time and PRN on all shifts are available. D ...
-
Medical Records Clerk II
4 days ago
SimonMed Imaging Phoenix, United StatesJob Description · Job DescriptionGENERAL DESCRIPTION/POSITION GOAL: · I. JOB RELATED FUNCTIONS: · Demonstrates competency in the performance of job related skills appropriate to his/her customer populations and departmental services. · Responsible for continuous follow ups on a ...
-
Tactile Medical Phoenix, Arizona, United States PermanentOverview: · Associate Territory Account Manager's are responsible for selling Tactile Medical devices and educating physicians, clinicians and patients on our medical devices that are clinically proven to improve the quality of life for Lymphedema patients. · Responsibilities: · ...
-
IT Tier 2, Tech Support, Medical Device
4 weeks ago
IQVIA Holdings, Inc. Phoenix, United StatesIT Tier 2 - Technical Support Representative Mon - Fri 11 am - 8 pm ET - Contract Remote Role Location (Open to Remote US) As the only global provider of commercial solutions, IQVIA understands what it takes to deliver nationally and internationall Medical, IT, Technical Support, ...
Quality Engineer II-Medical Devices - Scottsdale, United States - West Pharmaceutical Services
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
FULLY ONSITE POSITION
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.
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:
In this role, you will plan, schedule, execute and communicate all items regarding quality issues, complaints, validations and other projects to QA Senior Supervisor and Program Manager and/or other interested parties.
Essential Duties and Responsibilities:
Basic Qualifications:
Equivalent Experience:
Preferred Knowledge, Skills and Abilities:
Travel Requirements:
Physical & Mental Requirements:
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.
#LI-KR1