Quality Assurance Specialist, engineer

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Job description

Medical product solutions company seeks a Quality Assurance Specialist ensuring the quality management system supporting 21 CFR Part 820, ISO 13485. The individual is responsible for introducing and maintaining quality system procedures, system improvements, corrective and preventive actions (CAPA), internal audits, change orders, training, product structuring and unique device identifier labeling.

Responsibilities
Develops and/or generates metrics to support management reporting requirements.

Participates and/or develops and monitors key performance indicators.

• Develops and/or supports business acquisition strategies and quality plans.
• Creates and maintains required quality system documents and records
• May function as a subject matter expert for FDA and Notified Body external audits.
• Assists in preparation and follow up for Management Review meetings.
• Generates and/or conducts process evaluations.
• Supports and/or functions as a Lead Auditor for Internal Audits.
• Supports and/or conducts the Agile Change Control Board and the Business Change Control Board.
• Supports and/or generates quality system software requirements and validation protocols.
• Duties may be modified or assigned at any time to meet the needs of the business.
• Uphold the Company's core values of Integrity, Innovation, Accountability, and Teamwork.
• Etc.

Qualifications
Required

• Bachelor of Science in Engineering, or equivalent professional experience.
• Medical Device Experience:
  • 2-3 years' of experience working in quality, manufacturing or engineering disciplines in the medical device industry.
• Quality Assurance Experience:
  • 1-3+ years' experience with CAPA, NMR, Quality System Process Management and/or Change Control; ISO 13485 Auditor Training

Desired

• ASQ certifications in ISO 13485 and 21CFR 820 Compliance of medical devices.
• Familiarity with statistical analysis and six sigma methodologies.
• Experience operating under design control and Good Manufacturing Practices.
• Proficiency with Microsoft Office, Oracle Agile PLM, ComplianceWire.

To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless in accordance with the Company's COVID-19 Vaccination Policy.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.

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 (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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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