(Archived) Technical Quality Control Supervisor

• Oversee troubleshooting of in-line rotor testing for assessing product suitability
• Administer and support manufacturing investigations prompted by both complaints and non-conformances for root cause analysis and identification of corrective and preventative actions
• Supervise team of QC analysts, providing technical training and mentorship
• Provide technical guidance on issues pertaining to manufacturing and technical operations, oversee and coordinate the activities of technical staff.
• Support process optimization to enhance cGMP compliance and identify process improvements while applying continuous improvement tools
• Track and trend production failure modes; publish Pareto and trend analysis reports to generate focus on significant improvement opportunities
• Lead continuous improvement activities including SIPOC product mapping, defining CTQ process steps, and establishing or updating DOPs and SOPs
• Author and conduct DOEs, assist with validations, and work on similar special assignments with minimal supervision, including leading and directing work of others
• Provide input and support with developing controlled procedures and manufacturing records
• Oversee equipment maintenance and calibration; assist with root cause analysis
• Perform performance investigations; provide resource support for qualifications, validations and other requests as assigned
• Oversee department processes, suggest efficiencies, and ensure production scheduling demands are met

Additional Skills:

• Minimum two (2) years experience leading a Quality Control or Technical Operations team within a medical device field
• Strong technical scientific and laboratory skills including statistical analysis, experimental design, lab protocols/reports, calibration, lab safety, bio-hazard and chemical handling, and diagnostic product performance knowledge
• Hands-on experience and demonstrated good judgment in troubleshooting complicated products
• Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, or similar software
• Fast learner with excellent written and verbal communication
• Demonstrated organizational, prioritization, and time management skills
• Solid collaboration and team skills
• Ability to multi-task and work independently
• Experience with leading projects

Educational Requirements:

• BS/MS in Biological/Chemistry/Chemical Engineering or related field
• Process Excellence training preferred