Quality System & Design Assurance Engineer Contractor - Onsite chez RQM+
RQM+ · Newton, États-Unis d'Amérique
- Bureau à Newton
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
Quality System & Design Assurance Engineer Contractor
Hybrid- onsite 3 days a week
Newton, MA
12-month contract
Primary Responsibilities:
- Conduct comprehensive gap assessments of existing DHFs and Risk Management Files (RMFs) against current regulatory and internal requirements.
- Remediate and update documentation including design inputs/outputs, verification and validation (V&V), and traceability matrices.
- Review and revise risk management documentation in accordance with ISO 14971, including hazard analysis, FMEA, and risk-benefit analysis.
- Collaborate with cross-functional teams (R&D, Quality, Regulatory) to gather missing documentation and ensure alignment with current practices.
- Support internal and external audit readiness by ensuring documentation is complete, accurate, and audit-ready.
- Participate in CAPA investigations related to design and risk documentation gaps.
- Maintain detailed records of remediation activities and provide regular updates to project stakeholders.
Requirements:
- Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field
- 3+ years of experience in the medical device industry, with a focus on quality systems, design controls or risk management
- Strong knowledge of ISO 13485, ISO 14971, and 21 CFR 820.30. Familiarity with the Medical Device Single Audit Program (MDSAP) approach is a plus.
- Experience with DHF and risk file remediation projects is highly preferred
- Proficient in technical writing and document control systems. Experience using AutoCAD or similar drawing package is a plus.
- Excellent organizational, analytical and communication skills.
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.
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All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
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