03 Nov
Quality Control Supervisor (Medical Device)
Vacancy expired!
- At least 4 years of increasingly responsible experience working as a QC Engineer in medical device or biotech product development and manufacturing (IVD experience a plus)
- Have working knowledge of regulated quality, 21 CFR 820 and ISO 13485, design controls, inspection methods, good working knowledge of statistical methods, design verification and validation, and process validation and control
- Experience leading a small team of technicians; able to work in fastpaced projects in controlled environments (e.g., laboratory or manufacturing settings).
- B.Sc. in Engineering or Science related field or equivalent applicable experience
- Ability to lead projects and participate as a testing and quality subject matter expert in team environments
- Excellent written and verbal communication skills - able to train others in quality principles and operations
- Applicable knowledge of Microsoft Office (including Excel) along with general computer experience in order to use and expand corporate data/document/project systems and install, operate, and monitor test equipment
- Ability to read and interpret mechanical drawings (GD&T), electrical schematics (ANSI), and software specifications/flow charts (ISO)
- Ability to sit, stand, walk, bend, and lift up to 25 lbs.
- Create and deploy technically and statistically sound testing SOPs that adhere to quality guidelines
- Be capable of creating/updating procedures to align with regulatory compliance and standards
- Mechanically inclined and experienced in working with other engineers to design and construct test setups and create documented instructions and procedures
- Lead efforts to define requirements and guide enhancements to quality management system IT infrastructure for more efficient test execution and collaboration
- Drive continuous improvement of testing throughout the development cycle with testing methodologies that better extract information for assessment of non-conformances and support cross-functional root cause analysis
- Be able to perform SPC, design verifications, product and manufacturing validations, and risk analysis; advise on testing statistics
- Working knowledge of a wide variety of measurement and test equipment, including hand tools/instruments; able to research and specific additional testing systems
- Ability to meet deadlines under pressure; able to occasionally work extended or non-standard scheduled to meet specific personal training, department, and production needs
Vacancy expired!