Jobs
>
quality engineer
>
Minneapolis

    Quality Engineer - Minneapolis, United States - Integer Holdings Corporation

    Integer Holdings Corporation
    Integer Holdings Corporation Minneapolis, United States

    3 weeks ago

    Default job background
    Description


    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

    At Integer, our values are embedded in everything we do.
    Customer
    We focus on our customers' success
    Innovation
    We create better solutions
    Collaboration
    We create success together
    Inclusion
    We always interact with others respectfully
    Candor
    We are open and honest with one another
    Integrity
    We do the right things and do things right

    Job Summary:


    The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.

    Provide work direction for 3-5 Technicians/Inspectors.
    Key Accountabilities and Responsibilities

    Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S.

    Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.

    Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

    Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.

    Leads and implements various product and process improvement methodologies.

    Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.

    Leads in the completion and maintenance of risk analysis.
    Leads generation and completion of protocols and reports for test method validations.
    Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
    Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.

    Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

    Effectively communicate and interact with customers.
    Leads and manage complaint investigations.

    Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

    Assists with product transfers.
    Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.

    Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.

    Provides support to other quality engineers.
    Performs other functions as required.
    Job Requirements

    Minimum Education:
    Bachelor's degree in engineering or related field required


    Minimum Experience:
    5-7 years' experience in medical device or regulated manufacturing

    Specialized Knowledge:
    Competence in the selection and use of Quality Engineering Tools and Techniques. Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab
    Ability to work independently and in team environment.
    Ability to effectively communicate written and verbally.
    Ability to manage time effectively to ensure timely completion of tasks.
    Knowledge of SPC, FMEA, DOE, RCA, GDT Sound knowledge of quality management systems.
    U

    S Applicants:
    EOE/AA Disability/Veteran

    #J-18808-Ljbffr
  • Mid-Continent Engineering, LLC

    Quality Engineer

    2 weeks ago

    Mid-Continent Engineering, LLC Minneapolis, United States

    Job Description · Job DescriptionSummary: · Plans & directs activities concerned with development, application, and maintenance of quality standards for processes, materials, and products. Develops, initiates standards & methods for inspection, testing, and evaluation. · Essenti ...

  • Actalent

    Quality Engineer

    1 day ago

    Actalent Minneapolis, United States

    : The Quality Engineer will be an integral part of the Quality Assurance team. The majority of their duties will be focused in supporting one of our largest customer, Polaris. They will be interfacing with customers frequently to handle complaints, preparing PPAP packages, workin ...

  • Lake Air Metal Products, LLC

    Quality Engineer

    1 day ago

    Lake Air Metal Products, LLC Minneapolis, United States

    Lake Air Products is a fast-growing company that is proud to live by our Core Values, Customer Focus, Passion for Performance and Right People - Best Teams.We are currently adding a Quality Engineer to our growing quality department in New Hope, MN. This is a 1st shift position, ...

  • Integer

    Quality Engineer

    1 week ago

    Integer Plymouth, United States

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success ...

  • Dynamic Group

    Quality Engineer

    1 week ago

    Dynamic Group Minneapolis, United States

    Quality Engineer Dynamic Group Ramsey, MN Dynamic Group is a premier plastic injection molding and mold building company with two locations in the Northwest suburbs of Minneapolis, MN. We provide medical molded parts in our Ramsey location where prod Quality Engineer, Engineer, C ...

  • Mactac North America

    Quality Engineer

    1 week ago

    Mactac North America Minneapolis, United States

    Job Description · Job DescriptionPosition Summary · The Quality Engineer, under the direction of the remote Quality Assurance Manager, ensures compliance with the company ISO 9001 Quality Management System. The Quality Engineer will support the development, implementation, and ma ...

  • Medix

    Quality Engineer

    4 weeks ago

    Medix Minneapolis, United States

    Summary Statement: · Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the ...

  • Wagner Spray Tech

    Quality Engineer

    2 weeks ago

    Wagner Spray Tech Minneapolis, United States

    Job Description · Job DescriptionPosition Objective: · Assure Wagner Spray Tech products conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. Through active participation and involvement, lead efforts to support sup ...

  • Cummins

    Quality Engineer

    3 weeks ago

    Cummins Minneapolis, United States

    **Quality Engineer** · **Description** · Our culture believes in _POWERING YOUR POTENTIAL_ . We provide global opportunities to develop your career, make your community a better place and work with todays most innovative thinkers to solve the worlds toughest problems. · We bel ...

  • Wipro

    Quality Engineer

    1 week ago

    Wipro Minneapolis, United States

    Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs. We leverage our holistic portfolio of capabilities in consulting, d ...

  • Inspire Medical Systems I

    Quality Engineer

    2 weeks ago

    Inspire Medical Systems I Minneapolis, United States

    Job Description · Job DescriptionABOUT INSPIRE MEDICAL SYSTEMS · Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical ...

  • Medix

    Quality Engineer

    3 weeks ago

    Medix Minneapolis, United States

    Summary Statement: · Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the hi ...

  • EPM Scientific

    Quality Engineer III

    1 week ago

    EPM Scientific Minneapolis, United States

    JOB SUMMARY: · The Quality Engineer III is responsible for executing comprehensive quality and reliability engineering activities for both systems and products. This role requires expertise in engineering, physical sciences, and quality sciences. The engineer will lead projects a ...

  • EPM Scientific

    Quality Engineer III

    1 week ago

    EPM Scientific Minneapolis, United States

    JOB SUMMARY: · A well-established Multi-Industry contract manufacturer has recently shifted the majority of their focus towards the medical device industry. Within the last 18 months, they have gotten the green light to allocate resources towards a growth target of 300% of curren ...

  • Honeywell

    Sr Quality Engineer

    3 weeks ago

    Honeywell Minneapolis, United States

    Design solutions to drive safe living and quality of life · Sr. Quality Engineer · This dynamic position is a key member of our Quality team and will be responsible for Quality Engineering and Continuous Improvement activities relating to external customers, internal processes, ...

  • a Medical Devices company located in MN

    Manufacturing Quality Engineer

    1 week ago

    a Medical Devices company located in MN Minneapolis, United States

    Responsibilities · Develop, implement, and continuously improve manufacturing processes to enhance yield, reduce costs, and boost productivity. · Represent Process Engineering in R&D and Project Team meetings, offering technical expertise in technology transfers, analytical metho ...

  • Tennant Company

    Quality Engineer Intermediate

    6 days ago

    Tennant Company Minneapolis, United States permanent

    With more than $1B in revenue, Tennant Company is a globally recognized leader in the cleaning equipment industry. For the past 150 years, we have been passionate about developing and manufacturing innovative and sustainable solutions for our customers. At Tennant Company, we are ...

  • EPM Scientific

    Quality Engineer III

    2 weeks ago

    EPM Scientific Minneapolis, United States

    JOB SUMMARY: · The Quality Engineer III is responsible for executing comprehensive quality and reliability engineering activities for both systems and products. This role requires expertise in engineering, physical sciences, and quality sciences. The engineer will lead projects a ...

  • STERIS

    Senior Quality Engineer

    2 weeks ago

    STERIS Plymouth, United States

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. · Position Summary · The Senior Quality Engineer is responsible for managing processes and leading projects to m ...

  • STERIS

    Senior Quality Engineer

    1 week ago

    STERIS Minneapolis, United States

    Steris Corporation · Senior Quality Engineer · Plymouth , · Minnesota · Apply Now · Job Title: Senior Quality Engineer Req ID: 42117 Job Category: Quality Plymouth, MN, US, 55447 Description: At STERIS, we help our Customers create a healthier and safer world by providing in ...