Principal Quality Engineer

Note: This is a refined version of the job description to ensure proper formatting and clarity. The content preserves the original information while removing duplicates and non-essential boilerplate. Overview Principal Quality Engineer role at Recor Medical. The Principal Quality Engineer is responsible for ensuring adherence to Good Manufacturing Practices (GMP) in all manufacturing work cells and Good Laboratory Practices (GLP) in all manufacturing and Quality Control laboratories. The role involves applying tactical skills in a collaborative environment with cross-functional departments and ensuring compliance with quality and regulatory requirements. Base pay range $172,000.00/yr - $186,000.00/yr Additional compensation types Annual Bonus Responsibilities and Duties Supports development of the inspection process, validation of the inspection equipment, works with R&D and manufacturing to inspect and analyze new materials from suppliers, and improves the current inspection process. Leads nonconforming material (NCMR) root cause analyses, investigations, corrections, and corrective actions with cross-functional teams such as Operations, R&D, and Regulatory Affairs. Proactively identifies and assesses areas for continuous quality improvements in Incoming quality, In-process quality, and Final quality inspection. Reviews validation protocols/reports, interprets and assists in statistical analysis of inspection/test data using JMP. Assists in collecting and trending NCMR data for biweekly/monthly/quarterly reviews. Assists in equipment event investigations with Operations/R&D cross-functional teams. Ensures QC equipment is qualified (IQ/OQ/PQ), calibrated and maintained. Runs MRB meetings, writes minutes, and follows up with NCMR owners in a timely fashion. Supports internal and external audits as the subject matter expert of the Quality Control/Final Quality Control areas with in-depth understanding of manufacturing processes. Responsible for the training and development of Quality Control personnel/Junior Engineers. Ability to multi-task with attention to detail and apply risk-based problem solving. Other essential duties as directed. Requirements Bachelor of Science degree in scientific discipline or engineering. Minimum of 12+ years of quality experience in the bio-medical device industry (preferably Class III/Class II) related to manufacturing operations, quality control, and quality engineering. Working knowledge of GMP requirements and regulations: FDA CFR, ISO 13485 and other applicable industry standards. Knowledge of SOPs and Quality Control requirements in a GMP setting. Experience in writing SOPs and developing and monitoring quality improvement plans and SOPs. Experience with qualifications, technology and method transfer, and validation/verification of analytical methods. Experience using root cause analysis tools such as Ishikawa (fishbone) diagram, fault tree, contradiction matrix, 5 Whys. Experience in collecting and reviewing data to perform trend analysis. Ability to work independently, self-motivated, and with a sense of urgency to drive results. Effective at dealing with change and ambiguity, demonstrating flexibility while ensuring compliance. Excellent verbal and written communication skills and comfortable presenting to small and large groups. Expertise in statistical software such as JMP, Minitab, etc. CQE certified Quality Engineer (a plus). Six Sigma Black/Green Belt (a plus). Proficiency in Excel, PowerPoint, Visio, and Word. Seniority level Mid-Senior level Employment type Full-time Job function Engineering, Quality Assurance, and Manufacturing Medical Equipment Manufacturing ≥ Referrals increase your chances of interviewing at Recor Medical by 2x. Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Paid paternity leave Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Quality Engineer” roles. Location and additional postings shown are examples and may not reflect current openings. #J-18808-Ljbffr

Created: 2025-09-18