fbpx

Senior Quality Engineer

Healthcare

Department: QA/RA

Job ID: JP0054

Employment Type: Full time Exempt

Location: Eden Prairie, Minnesota

Job Posting Details:

RxFunctionhttps://rxfunction.com/https://rxfunction.com/wp-content/uploads/2018/10/logo-rxfunction-2022.png

Job Summary:

We are seeking a highly skilled and experienced Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for establishing and implementing the methods required to meet technical quality standards across the company. This will require frequent interaction with cross-functional teams and personnel, especially peers in Operations and Engineering, to develop and manufacture marketed medical devices and to support project and objective completion.

Duties:

  • Identify and implement appropriate technical quality standards, methods and acceptance levels
  • Oversee the quality inspection / test program, including the selection of suitable equipment and sampling plans, the development of methods and procedures, and the training of personnel
  • Lead the Material Review Board (MRB) and ensure the proper disposition of nonconforming products and the timely processing of documentation
  • Work directly with suppliers to resolve quality issues
  • Represent the Quality function on product development projects and complete assigned tasks and deliverables per schedule
  • Conduct and document failure investigations for products and processes, including in support of customer complaints, nonconforming events, and CAPA
  • Work with other engineering functions to: identify and estimate product and process risks, plan and implement needed controls, and monitor and measure critical performance indicators
  • Provide technical quality inputs into product and process validations to ensure that outputs consistently meet specified requirements and quality standards
  • Make recommendations for product and process improvements
  • Support third-party, supplier and internal quality audits as a technical expert
  • Other duties as assigned

Qualifications:

  • Four-year technical degree (engineering, mathematics, statistics)
  • Seven years’ experience in a quality assurance role(s); medical device experience preferred
  • Solid knowledge of relevant FDA regulations and quality management system standards, including 21 CFR 820 and ISO 13485
  • Ability to read and accurately interpret dimensional requirements on drawings and specifications
  • Advanced knowledge of root cause analysis and continuous improvement methods
  • Ability to apply valid statistical models and techniques (T-test, F-test, ANOVA)
  • Demonstrated proficiency in process validation design and analysis of results, including IQ-OQ-PQ and Gage R&R studies
  • Identify, estimate and control product and process risks using suitable methods
  • Desire and ability to train and mentor other technical staff
  • Excellent communication skills, both verbal and written
  • Advanced computer skills, e.g., MS Office®, Minitab® or other statistical software

We offer competitive compensation packages, including benefits and opportunities for professional development and growth. If you are a highly motivated and detail-oriented individual with a passion for quality, we would love to hear from you.

Note: This is a paid position, and all applicants must be eligible to work in the specified location.

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift

Work Location: In person

Apply For Senior Quality Engineer

  • Accepted file types: pdf, doc, docx, Max. file size: 8 MB.