Lead Quality Engineer

Spectrum Plastics Group•Brokenstraw Township, PA

6d•$80,000 - $90,000•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

Experience with programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred

Responsibilities

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
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