1+ months

Direct Hire - Principal Quality Engineer (Design)

Kelly Services
St Louis, MO 63103
**Direct Hire opportunity for a Principal Quality Engineer (Design) for the St. Louis, MO area!!!**

**Dont miss out on this opportunity, apply today.**

**Type: Direct Hire**

**Schedule: Monday Friday**

*****Relocation assistance offered for qualified candidates*****


+ Responsible to assure Quality and Compliance, and provide overall Quality guidance during product design and development, design verification and validation, and design transfer to manufacturing.

+ Represent Design Quality on multi-disciplinary new product development and MOB teams.

+ 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). Documentation of Risk Management requirements per ISO 14971.

+ Review/approve GMP documents (e.g. production records, analytical method validation, engineering/validation protocols/reports, specification updates (DCOs, QCRs).

+ Facilitate GMP production readiness and launch activities, including technology transfer and validation.

+ Support Quality System development and improvement with respect to GMP systems and development team compliance to ISO and FDA regulations.

+ Support post launch design changes and product updates as required.

+ Responsible to defend in any Quality audits and Regulatory inspections the Design Quality aspect of the products under his/her responsibility.

+ Owns and leads CAPAs initiated for findings in Design Quality procedures and practices.

+ Identify, develop and implement specific metrics to monitor Design for Quality across product lines with active R&D projects.

+ Provides coaching and training on critical Quality procedures and practices to entry level Design Quality Engineers and/or contractors as part of their onboarding process.

+ Perform assessments of Quality processes and procedures relative to product design and development, in order to identify potential inefficiencies, and where needed, propose and implement changes to improve those processes.

+ Proactively participates as owner of site Quality deliverables in corporate projects and initiatives towards continuous improvement of product Quality and/or the Quality management system.

**Required Skills/Qualifications:**

+ 5-years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R&D, Engineering or Laboratory environment.

+ Bachelors Degree (BS) in engineering or scientific discipline (Chemistry, Biology, Microbiology).

+ 5 years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices.

+ Advanced experience in Six Sigma, DFSS or Lean Development techniques in a regulated environment.

+ 1 year utilizing corrective and preventive action (CAPA) system that is in compliance with US federal and international regulatory standards relating to medical devices.

+ 1-year Complaint management, complaint review and corrective action.

+ 1-year Utilization of root cause analysis tools, including fault tree analysis, 5 Whys, Is/Is Not. 3 years risk analysis experience

+ Thorough understanding of Design Controls requirements for medical devices, as well as best practices that foster high quality design.

+ Deep knowledge of Design History Files.

+ Excellent analytical, problem solving, organizational, and communication skills.

**NOTE: This position is not being recruited by your local Kelly branch. To be considered for this position, please email a current resume to** ****

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping
you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ
each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.
Posted: 2019-08-23 Expires: 2019-10-14

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Direct Hire - Principal Quality Engineer (Design)

Kelly Services
St Louis, MO 63103

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