Lead Quality Engineer

JOB SUMMARY:

This hybrid role is responsible for both executing quality engineering activities and supervising the Quality Control (QC) inspection team. The position ensures that products meet internal specifications, customer requirements, and regulatory standards through robust inspection, process control, and quality system oversight. The individual will lead problem-solving efforts, manage QC operations, and support continuous improvement initiatives across manufacturing.

QUALITY ENGINEERING DUTIES:

• Participate in validations (IQ/OQ/PQ) and process qualifications
• Analyze quality data and generate reports on trends and improvements
• Execute Gage R&R/test method validation
• Perform risk analysis (FMEA) and process capability studies
• Develop and maintain control plans and inspection plans
• Lead root cause investigations and corrective/preventive actions (CAPA)
• Lead and maintain change control efforts

• Conduct layered process audits and support internal/external audits

QUALITY CONTROL SUPERVISION:

• Supervise day-to-day QC inspection activities across shifts
• Provide training, coaching, and schedule for QC inspectors
• Ensure proper use of measuring equipment and adherence to Good Documentation Practices (GDP)
• Ensure timely review and disposition of nonconforming product
• Drive compliance with procedures and standard work at the inspection level
• Maintain equipment calibration compliance (including scheduling and quoting)
• Perform employee annual reviews and individual management
• Develop and maintain Quality Lab metrics / KPIs
• Perform other duties as assigned

EXPERIENCE, SKILLS, EDUCATION AND TRAINING:

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

• Bachelor’s Degree or equivalent, or 3-5 years’ related experience and/or training, or equivalent combination of education and experience in quality engineering in the medical industry
• Knowledge of regulatory requirements and industry standards (e.g., FDA QSR, ISO 13485).
• Strong understanding of quality management systems, material inspection techniques, and root cause analysis methodologies.
• Knowledge of GD&T print interpretation, CAD Models, Statistical technique and Software, Programming CMM’s, Validation Activities (IQ, OQ, PQ), Cleanroom practices, Sampling Technique.
• Proficiency in data analysis and problem-solving tools (e.g., 8D, FMEA, Pareto analysis).
• Experience leading or participating in CAPA investigations and resolution activities.
• Proficiency in problem-solving tools and techniques (e.g., 5 Whys, Fishbone diagram, DMAIC).
• Above average math skills (sound knowledge in both statistics and calculus)
• Ability to work with a high volume of documents in a fast-paced environment
• Experience with programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred
• Strong written, verbal, time management and interpersonal skills
• Ability to communicate effectively with all levels of staff and management, both internal and external
• Collaborate with cross-functional teams
• Leadership skills and team player
• Highly organized
• Must have a strong attention to details
• Strong Computer skills; Microsoft Office (Word, Excel) and Minitab
• Must be able to lift up to 25 lbs. 
• Must be able to sit or stand for long periods of time
• Must be able to climb up and down stairs
• Travel is required to support company initiatives