Process Quality Engineer
2 days ago
I. Job Summary
The Process Quality Engineer (PQE) is a vital role responsible for ensuring product quality, process integrity, and regulatory compliance within the production environment. The PQE acts as a key technical resource for resolving in-process issues, validating equipment and new products, and ensuring the highest standards of quality are maintained from raw material to finished goods.
II. Roles and Responsibilities
- Implement and maintain Statistical Process Control (SPC) programs: collect and analyze process data, create control charts, and work with production to reduce variability and improve process capability (Cp/Cpk).
- Lead Machine Validation activities (IQ/OQ/PQ) for new and existing equipment to ensure they are installed correctly, operate as intended, and produce results that meet predefined specifications.
- Manage the In-process Corrective Action Request (CAR) process: Investigate non-conformances, perform root cause analysis (e.g., 5 Whys, Fishbone), implement containment, and verify the effectiveness of corrective actions to prevent recurrence.
- Develop, audit, and maintain robust Identification and Traceability systems throughout the production process to ensure material and product lineage, support recalls, and meet customer and regulatory requirements.
- Conduct routine Production Audits to verify adherence to standard operating procedures (SOPs), work instructions, quality standards, and Good Manufacturing Practices (GMP).
- Lead and coordinate Validation Runs for New Product Development (NPD): partner with R&D and Production to execute trials, collect data, analyze results, and document evidence that the process can consistently produce product meeting all critical quality attributes.
III. Qualifications and Education Requirements
- Bachelor's degree in chemical engineering, Industrial Engineering, Mechanical Engineering, or a related technical field.
- Minimum of 3+ years of experience in a quality engineering or manufacturing engineering role within a production environment.
- Proven, hands-on experience with Statistical Process Control (SPC), machine/process validation (IQ/OQ/PQ), and root cause analysis methodologies.
- Strong understanding of Quality Management Systems (QMS) and relevant standards such as ISO 9001, GMP, or IATF 16949.
- Proficiency in reading technical drawings, GD&T, and using measurement equipment (calipers, micrometers, CMM, etc.).
- Excellent analytical, problem-solving, and documentation skills.
IV. Preferred Skills
- Certified Quality Engineer (CQE) or similar certification (e.g., Six Sigma Green Belt/Black Belt).
- Experience with Minitab or other statistical analysis software.
- Direct experience in a regulated industry (e.g., Automotive, Aerospace, Medical Device, Pharmaceuticals).
- Experience supporting New Product Introduction (NPI) or Development (NPD) projects.
- Strong project management and cross-functional collaboration skills.
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