12 days old

Sr. CAPA Engineer - CAPA Owner

Kelly Services
St Louis, MO 63112
**Sr. CAPA Engineer - Saint Louis, MO - Direct Hire**

The Senior CAPA Engineer will be responsible for Corrective and Preventive Action (CAPA) and Non-conformance (NC) processes and related quality activities.

+ The position also supports new quality system/methodologies implementation, training, and problem solving.

+ This position will also work directly with Site Quality, Global Quality and Site Functions and Departments to provide sustaining quality and compliance leadership in the specific areas related CAPA and Non-conformance, training, and problem solving. In addition, the position is responsible for reporting key quality metrics to drive quality and efficiency.

+ The position will develop and maintain Nonconformance and CAPA procedures in accordance with applicable requirements. This position also supports compliance remediation projects.

+ Other Quality System duties as directed by Quality leadership.

**Duties Include:**

+ Facilitate implementation of CAPA and NC systems. Mentor, coach, and guide users of the CAPA and NC systems, including problem solving tools, root cause investigation, CAPA action determination, CAPA effectiveness.

+ Monitor quality of CAPA and NC records and work with owners to address issues.

+ Contribute to the continuous improvement of the CAPA and NC systems based on use patterns and user feedback. Develop, implement and manage CAPA Review Board.

+ Develop and report quality metrics on CAPA and NC performance.

+ Assist functional areas with systematic problem-solving methodologies when resolving issues.

+ Assure compliance to applicable regulations.

**Qualifications Required:**

+ Bachelor of Science degree in an engineering discipline (Mechanical, Biomedics, materials, Industrial, etc.) or related technical field (microbiology, chemistry, etc.) is required.

+ Lean Six Sigma Certification. Preferred ASQ Certification (such as CQA, CQE, CMQ/QE).

+ Preferred Demonstrated working experience and expertise in CAPA and non-conformance systems in a regulated industry.

+ Excellent communication skills (verbal and written).

+ Experience in problem solving and root cause analysis.

+ Ability to successfully coordinate and influence other within project teams regarding quality or compliance concerns.

+ Excellent organizational and presentation skills.

+ Minimum 5 years with CAPA and NC in Quality Assurance industry is required, including; root cause analysis and statistical techniques such as Cause and Effect Analysis, 5 Whys, Six Sigma processes.

+ Medical Device or Pharmaceutical is preferred.

+ Ability to motivate and mentor users to increase proficiency with CAPA and NC management along with problem solving tools.

+ Expertise in implementing and maintaining quality systems.

+ Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment.

+ Familiar with 21 CFR Part 820 and ISO 13485.

**Work Authorization:**

+ Workers must have US Work Authorization in possession prior to start without sponsorship as **US CITIZEN or GREEN CARD HOLDER.**

**Important information:** To be immediately considered, please send an updated **WORD DOCX** version of your resume to

**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, 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: 2020-01-10 Expires: 2020-02-10

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Sr. CAPA Engineer - CAPA Owner

Kelly Services
St Louis, MO 63112

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