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15 days old

Sr. Quality Engineer

Kelly Services
St Louis, MO 63103
**Quality Engineer - Sr. Design Quality Engineer - HRC Req 5424**

**Direct Hire**

**Salary Negotiable- Depending on Experience**

**On-site**


+ 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 DCO s, QCR s .

+ 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.

+ 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 ensure medical device development activities are planned and executed in compliance with Design Control Requirements and Bausch + Lomb/ Bausch Health 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.


**Required Education: - Bachelor s Degree BS in engineering or scientific discipline Chemistry, Biology, Microbiology .**


**Required Skills/Qualifications:**


+ 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 Required Experience: 3 years of experience in Medical Device and/or Pharmaceutical Industry in Quality, R D, Engineering or Laboratory environment.

+ 3 years developing and implementing product requirements in compliance with US federal and international regulatory standards relating to medical devices.

+ 3 years using Six Sigma, DFSS or Lean Development techniques in 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.

+ 1 year risk analysis experience.


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


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**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 (plus, did we mention we provide a ton of benefits ?). 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-19 Expires: 2022-10-20

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Sr. Quality Engineer

Kelly Services
St Louis, MO 63103

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