Saint Louis, MO 63146
- The Quality Manager provides quality oversight for design control lifecycle activities for the auto injector platforms.
- Provides Quality input and review for combination product related design projects, quality system records and design control procedural deliverable requirements.
- Guides design verification and validation plans.
- Assesses and improves systems, procedures and practices.
- Approves protocols and reports as needed.
- Responsible for oversight of Design Control Lifecycle.
- Provides Quality oversight for R&D, human factors and design verification activities.
- Provide oversight to the Product Technology team, R&D and STL manufacturing site to ensure compliance with FDA’s regulations / guidance documents as well as site SOPs
- Review/Approve impact assessments for complex/significant CAPA and Change Management records and develop execution plans
- Facilitate risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed
- Review and Approve Design History and Risk File documentation
- Utilize Design History and Risk File documents to assess risk resulting from complex/significant changes, manufacturing events and customer complaints
- Perform periodic reviews of Design History and Risk File documents to ensure the files remain reflective of data/trending signals and ongoing activities
- Provide direction and approval for engineering and development documentation
- Provide guidance and approval for protocols and reports ensuring adherence to design control procedures and policies
- Provide guidance and oversight for design verification and validation activities.
- Lead investigations of device failures to determine root cause and work with teams to implement appropriate corrective and preventative actions
- Provide oversight of new drug delivery system projects to R&D and other technical teams
- Review/Approve Combination Product technical assessments
- Represent the Quality Unit during Design Reviews
- Provide Design Control lifecycle, procedure and policy training as necessary.
- Identify and correct deficiencies in procedures and practices
- Represent the Quality Unit during regulatory inspections and audits
- Bachelor’s Degree in Engineering or Science
- 7-10 years’ experience in medical device or combination product manufacturing within the Quality function
- At minimum 5 years providing direct oversight to the design control lifecycle, human factors studies and DHF
- Well versed in ISO13485 and 21CFR820 requirements
- Critical thinking ability and attention to detail
- Effective technical writing ability and verbal communication skills
- Computer skills including MS Office and MiniTab
- Demonstrated applied knowledge of Failure Modes Effect Analysis (FMEA), CAPA, Root Cause Analysis and statistical methods as applied to Quality.
- Certified Quality Engineer, Quality Manager or Six Sigma Black Belt preferred
- Experience with DHF remediation preferred
- May require work beyond typical business hours
- Requires travel ~30%
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.
Director of Recruiting
Anne Cleveland is the Director of Recruiting at HKA Enterprises. She specializes in recruiting for the pharmaceutical and power industries. Anne's advice to job seekers is "avoid having your resume fall into a black hole after applying by following up your online application with a quick phone call, text, or email directly to the recruiter listed on the job posting." The best way to reach Anne is via text or email.