Senior Design Assurance / Quality Assurance Engineer
Arsenal Medical Inc. is a Boston metro based, privately held, clinical stage, medical device start-up company committed to transforming medicine through the novel application of in situ forming materials to meet today's challenging unmet clinical needs. Our in situ forming biomaterials platform creates customized mechanical implants in the body to control the flow of bodily fluids, fill complex anatomical spaces, and/or apply physical pressure. These implants are formed by delivering liquids with tunable chemistries to specific locations in the body using minimally invasive delivery systems. Once at the target anatomy, the liquids react to form solid implants that take the shape of complex cavities in the body. We create solutions that address some of today’s most challenging and critical unmet medical needs
We have an opening for a hands-on, full-time Senior Design Assurance / Quality Assurance Engineer. This person must thrive in a fast-paced environment, be able to work on multiple product development and quality projects simultaneously and be motivated by the opportunity to learn. This is great opportunity to combine the use of engineering and quality skills.
- Represent Quality on product development core teams to ensure products meet corporate quality standards and applicable regulatory requirements including design controls throughout the product lifecycle. Responsible for completion of phase gate advancements.
- Complete product risk assessments throughout the product life cycle, coordinating cross-functional input and review
- Test method development: provide support including document approvals of qualifications / validations
- Protocol/Report development: provide support for test method validations, design and process verifications/validations, product batch release, and risk management reports
- Equipment qualification including IQ-OQ: assist project team in developing equipment IQ-OQ, maintenance and calibration protocols and finalize the executed reports
- Supplier controls: maintain and update the Approved Vendor List (AVL) as needed. Work with project teams to ensure required vendor deliverables are achieved in timely manner.
- Incoming inspection: review and disposition raw materials and components including non-conforming materials
- Non-conforming material (NCM) and/or Corrective and Preventative Actions (CAPA) investigations: support all phases of NCMRs and CAPAs from initiation to closure. Maintain the database and ensure timelines are met.
- Production and process controls: review and approve work instructions and the release of product via batch qualification to support clinical trials.
- Quality Management: promote and enhance the Quality Management System implementation across the organization. Maintain the document control, lab notebook and training documentation systems. Manage external consultants regarding the corporate quality system/audits.
- Minimum of a Bachelor's Degree in Engineering or Science or related discipline is required
- Minimum of 5+ years’ experience in Design Assurance and Quality Engineering in medical devices
- Background in Chemistry or experience with Chemistry-based products is desired
- Experience with ISO 13485, ISO 14971, and GMP CFR 820 is required, CFR 210/211 and applicable ICH guidelines is preferred
- Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC) is desired
- Proven contributor on product development teams
- Excellent written and verbal communication skills
If you are interested, please apply here