SR. QUALITY CONTROL MANAGER

Our world-class medical device manufacturing client near Boston has an immediate need to fill their open Senior Quality Control Manager position.

Reporting to the Chief Quality and Regulatory Affairs Officer this Sr. QC Manager will manage the quality control function, driving quality improvements and continuous improvement efforts associated with the quality of products and the processes and testing of analyzers and reagents.

Additional responsibilities include:

• Drive the current quality control practices of testing, data collection and reporting, ensuring compliance to FDA and ISO requirements
• Analyze and act upon quality reports and quality database, collect, summarize, and post data on quality metric performance
• Support the engineering and manufacturing quality improvements with procedures, processes and quality engineering tools with data and statistics to gauge effectiveness of improvements, and ensure compliance to customer requirements.

Education and Experience Requirements for Consideration:

• BS/BA degree in a technical discipline, preferably life sciences or medical technology
• At least 10 years of experience as a Quality Control Manager in an FDA regulated reagents, medical device or IVD manufacturing company
• Strong working knowledge of ISO 13485, IS9001 and FDA Regulations (21 CFR Part 820)
• A thorough understanding of quality improvement tools, i.e. Six Sigma and Lean Manufacturing along with a strong knowledge of statistical methods including statistical process control and sampling techniques
• Preference is for an ASQ Certified Quality Manager and Six Sigma Certification

If you are interested in learning more about our client company and this management opportunity please submit your Word-formatted resume to Steve East at [Click Here to Email Your Resumé].

Include in our cover letter the job title: Senior Quality Control Manager, and the job code: 121014 STE-C.

Key words include: quality, control, assurance, manage, medical, ISO, Lean, Sigma, FDA, SPC, ASQ, manager, device, reagent, analyzers, compliance.