Quality Engineer III

1 month ago

Brooklyn Park, United States Integer Holdings Corporation Full time

Quality Engineer III: 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.


  • Adheres to Integer 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.

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 Special Skills: 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.

Other: Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or Six Sigma Green Belt or Black Belt desired.

  • Quality Engineer III

    3 weeks ago

    Brooklyn Park, United States Integer Holdings Corporation Full time

    Quality Engineer III: 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. ...

  • Quality Engineer III

    4 weeks ago

    Brooklyn Park, United States Integer Holdings Corporation Full time

    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...

  • Quality Engineer III

    4 weeks ago

    Brooklyn Park, Minnesota, United States Integer Holdings Full time

    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' successInnovation We create better solutionsCollaboration We create success...

  • Quality Engineer III

    4 weeks ago

    Brooklyn Park, United States Integer Holdings Full time

    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...

  • Senior Quality Engineer

    2 weeks ago

    Brooklyn Park, United States Cypress Human Capital Management, LLC Full time

    A medical device company in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and manufacturing changes independent work at the supplier site . Responsibilities Support...

  • Senior Quality Engineer

    1 week ago

    Brooklyn Park, United States Cypress HCM Full time

    Job Description Job Description A medical device company in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and manufacturing changes independent work at the supplier...

  • Senior Quality Engineer

    3 weeks ago

    Brooklyn Park, United States Cypress HCM Full time

    Job DescriptionJob DescriptionA medical device company in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and manufacturing changes independent work at the supplier...

  • Manufacturing Quality Engineer

    1 month ago

    Brooklyn Park, United States Cypress HCM Full time

    A cutting-edge medical parts manufacturer in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will ideally come from Swiss Machining or Thermoplastics and will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and...

  • Manufacturing Quality Engineer

    1 month ago

    Brooklyn Park, United States Cypress HCM Full time

    A cutting-edge medical parts manufacturer in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will ideally come from Swiss Machining or Thermoplastics and will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and...

  • Quality Engineer II

    2 weeks ago

    Brooklyn Park, United States Cypress HCM Full time

    A cutting-edge medical parts manufacturer in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will ideally come from Swiss Machining or Thermoplastics and will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and...

  • Sr Engineer Manufacturing

    2 weeks ago

    Brooklyn Park, United States Cirtec Medical Full time

    This position is eligible for a $5,000 Sign-On BonusWHO WE ARE: For over three decades, Cirtec has been an industry-leading outsource partner for complex medical devices. Cirtec Medical provides outsourcing solutions for Class II and III medical devices. From design and development, to precision components and finished device assembly, Cirtec can help bring...

  • Design Drafter III

    4 weeks ago

    Brooklyn Park, United States Three Point Solutions Full time

    Job DescriptionJob DescriptionJob Title - Design Drafter III - Non-Exempt - 13988Number of Positions 1Job Location - Brooklyn Park, Minnesota 55428Role is required to be on sight at Brooklyn Park 4 days a week, Monday thru Thursday, along with the rest of the team. Individual will be on site 5 days initially until trained and proficient. . Once the...

  • Quality Engineer I

    7 days ago

    Brooklyn Park, Minnesota, United States Integer Holdings Full time

    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' successInnovation We create better solutionsCollaboration We create success...

  • Quality Engineer I

    1 month ago

    Brooklyn Park, United States Integer Holdings Full time

    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...

  • Field Service Technician III

    4 weeks ago

    Brooklyn Park, United States Qualus Services Full time

    Field Service Technician III Job Locations US-MN-Brooklyn Park ID 2024-2073 Category Field Services Position Type Regular Full Time Remote: No Position Overview The Field Service Technician III is responsible for the testing, maintenance and repair of low and medium voltage circuit breakers, transformers, switchgear, motor...

  • Field Service Technician III

    4 weeks ago

    Brooklyn Park, Minnesota, United States Qualus Services Full time

    Field Service Technician IIIJob LocationsUS-MN-Brooklyn ParkID CategoryField ServicesPosition TypeRegular Full TimeRemote:NoPosition OverviewThe Field Service Technician III is responsible for the testing, maintenance and repair of low and medium voltage circuit breakers, transformers, switchgear, motor control and other electrical apparatus in the shop and...

  • Software Engineer III- Golang

    1 week ago

    Brooklyn, United States JPMorgan Chase Full time

    Job Description We have an exciting and rewarding opportunity for you to take your software engineering career to the next level. As a Software Engineer III- Golang at JPMorgan Chase within the Corporate Sector, Infrastructure Platforms, you serve as a seasoned member of an agile team to design and deliver trusted market-leading technology products in a...

  • Software Engineer III

    4 weeks ago

    Brooklyn, United States JPMorgan Chase Full time

    Job Description We have an exciting and rewarding opportunity for you to take your software engineering career to the next level. As a Software Engineer III at JPMorgan Chase within AWM Data and Analytics team, you serve as a seasoned member of an agile team to design and deliver trusted market-leading technology products in a secure, stable, and scalable...

  • Quality Manager

    3 weeks ago

    Brooklyn Park, United States Cypress HCM Full time

    A growing medical device manufacturing company is looking to hire a Quality Manager in Brooklyn Park. This person will report to the VP of Operations and oversee Quality Engineers in the New Product Development and Sustaining Operations group as well as the Inspection Supervisor, Metrology Technicians and Receiving Inspectors. What You'll Do: Perform as Site...

  • Quality Manager

    7 days ago

    Brooklyn Park, United States Cypress HCM Full time

    A growing medical device manufacturing company is looking to hire a Quality Manager in Brooklyn Park. This person will report to the VP of Operations and oversee Quality Engineers in the New Product Development and Sustaining Operations group as well as the Inspection Supervisor, Metrology Technicians and Receiving Inspectors. What You'll Do: Perform as...