Senior Quality Engineer

LOCAL CANDIDATES TO LONDONDERRY, NH or MARLBOROUGH, MA RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better. We don't make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency. Job Summary: The Senior Quality Engineer (Contractor) will lead development of operational quality controls for legacy manufacturing processes. This role focuses on translating ISO 14971 risk management outputs and historical design documentation into manufacturing process controls, inspection strategies, PFMEAs, and Control Plans. Working closely with Manufacturing Engineering, Validation Engineering, and Operations, the engineer will develop PFMEAs, Control Plans, inspection strategies, and related production documentation. The role includes remediation and modernization of process validation (IQ/OQ/PQ) and Test Method Validation (TMV) activities to ensure alignment with FDA 21 CFR 820 Production and Process Controls and ISO 13485 requirements. Provides technical expertise and leadership to manage complex projects. Primary Responsibilities: * Review ISO 14971 Risk Management Reports to identify hazards, CTQs, and required risk controls. * Develop PFMEAs for legacy manufacturing processes. * Translate PFMEA outputs into Control Plans defining inspection points, monitoring methods, acceptance criteria, and reaction plans. * Develop and execute Test Method Validation (TMV) protocols for inspection and test methods verifying CTQs. * Ensure CTQs are controlled through incoming, in-process, and final inspection strategies. * Writes, reviews and/or approves reports for test method validations, design verification, design validation, and process validations (IQ, OQ, PQ) ensuring validation plans address CTQs and process risks. * Provide leadership in initiatives aimed at strengthening manufacturing quality controls. * Leads corrective and preventive actions (CAPA) projects to drive root cause analysis, implementation planning, implementation execution, and effectiveness checks. * Uses statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). Excellence through Integrity, Compliance, Safety and Environment * Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP). * Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation. * Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork. * Engage in continuous improvement initiatives, striving for operational excellence and efficiency. * Participate in regular training and complete all training on time. Education/Work Experience: * Bachelor's degree or Master's degree in Mechanical, Biomedical, Industrial, Electrical Engineering, or related discipline. * American Society for Quality (ASQ) Certified Quality Engineer (CQE) and/or Six Sigma certification. * 10+ years of Quality Engineering experience in medical device or regulated manufacturing environments. * Experience developing PFMEAs, Control Plans, inspection strategies, and CAPA investigations. * Experience with Process Validation (IQ/OQ/PQ) and Test Method Validation (TMV). Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning Requirements: * Excellent working knowledge of medical device regulations 21 CFR, ISO 13485, ISO 14971, IVDR, and other applicable standards. * Strong working knowledge of risk management and process validation, including TMV. * Excellent written, verbal, and presentation abilities. * Outstanding interpersonal skills to interact with all levels of the company, internal and external stakeholders, and oversight agencies. * Exceptional attention to detail, leadership, and computer literacy skills. Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds. Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity Verification At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: /careers Every candidate going through the interview process will participate in a voice and/or video interview. Exercise caution with unsolicited job offers or requests for sensitive information.

Created: 2026-04-02