Quality Engineer

Position Summary 

Provide support for Surgical development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility.   Additionally the role will support marketed product changes and updates (MOB). The role includes working with multidisciplinary teams to insure medical device development activities are planned and executed in compliance with Design Control Requirements and Client procedures.   Provide Quality Assurance support to sites as needed.

 

Work with Project Management to lead design teams through lean development methodologies to develop highly capable products.  Drive test strategies meeting right first time expectations.

 

Specific Job Duties

Represent Design Quality on multi-disciplinary new product development and MOB teams.  Duties will include:

  1. Ensure project plans adequately address design, validation and Quality departmental requirements and standards.  Work with functional departments to ensure tasks are executed compliantly.  Management and documentation of Design Control activities through post launch review (approximately 1 year post launch).
  2. Documentation of Risk Management requirements per ISO 14971.
  3. Review/approve GMP documents (e.g. production records, analytical method validation, engineering/validation protocols/reports, specification updates (DCO’s, QCR’s)
  4. Facilitate GMP production readiness and launch activities, including technology transfer and validation.
  5. Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.
  6. Support post launch design changes and product updates as required.

 

Qualifications

Bachelor’s Degree (BS) in engineering or scientific discipline (Chemistry, Biology, Microbiology).

 

Experience

Three years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R&D, Engineering or Laboratory environment. Specific experience desired is as follows:

  1. Three years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices.
  2. One year utilizing corrective and preventive action (CAPA) system that is in compliance with US federal and international regulatory standards relating to medical devices.
  3. One year Complaint management, complaint review and corrective action.
  4. One year Utilization of root cause analysis tools, including fault tree analysis, 5 Whys, Is/Is Not,
  5. One year risk analysis experience.

 

Managerial Responsibility

Currently there are no direct or indirect reports associated with this position.

Why Kelly®?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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