Quality Engineer
APEX RESOURCE TECHNOLOGY INC•Brokenstraw Township, PA
•$80,000 - $90,000
About The Position
This role is responsible for executing quality engineering activities. 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
- Experience working in regulated manufacturing environments
- Knowledge of cleanroom practices
- Strong understanding of regulatory requirements and industry standards (e.g., FDA QMSR, ISO 9001).
- Thorough knowledge of quality management systems, material inspection methods, and root‑cause analysis/problem‑solving tools.
- Proficiency in GD&T interpretation, statistical analysis, and sampling techniques.
- Skilled in the use of measurement tools including calipers, micrometers, vision systems, and CMMs.
- Strong working knowledge of PPAP, FMEA, control plans, SPC, and CAPA documentation and processes.
- Experience leading or contributing to CAPA investigations and corrective action activities.
- Ability to work with a high volume of documents in a fast-paced environment
- Ability to communicate effectively with all levels of staff and management, both internal and external
- Strong leadership, communication, and analytical skills
- Collaborate with cross-functional teams
- Strong Computer skills; Microsoft Office (Word, Excel) and Minitab
Responsibilities
- Participate in validations (IQ/OQ/PQ) and process qualifications
- Conduct capability studies, SPC monitoring, and data analysis to identify trends and improvement opportunities
- Develop control plans, perform risk analysis FMEAs, inspection instructions, and gage control practices (calibration, R&R / TMV).
- Investigate production quality issues, perform root cause analysis, and coordinate corrective actions
- Lead and maintain change control efforts
- Conduct layered process audits and support internal/external audits
- Develop, manage, and improve the facility’s Quality Management System, ensuring compliance with ISO 9001 or customer-specific standards.
- Maintain and update quality assurance procedures, documentation, and inspection standards for injection molding operations
- Implement proactive and reactive quality measures to reduce defects, improve process efficiency, and control variation
- Serve as the main point of contact for customer quality issues
- Manage customer complaints, documentation, and resolution activities
- Train, mentor, and support quality and production staff to ensure understanding of standards, inspection methods, and best practices
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
