Quality Engineer —

Medical Device Location:

Millersville, MD (on-site) About the Role Threadstone LLC is an FDA-registered, ISO 13485:2016-certified manufacturer of braided UHMWPE surgical sutures and suture tapes, supporting orthopedic and sports medicine device companies through OEM, white-label, and contract manufacturing. We're looking for a Quality Engineer to help maintain and grow our Quality Management System as we expand our product lines and customer base. This is a hands-on role for someone who wants ownership across the full product lifecycle — from design input through post-market surveillance — rather than a narrow slice of QA. You'll work directly with engineering, operations, and regulatory to keep our DHFs, risk files, and 510(k) submissions audit-ready while contributing to new suture line development. What You'll Do Design Controls & DHF Management Build and maintain Design History Files (DHF) for new and existing suture product lines per 21 CFR 820.30 and

ISO 13485

2016 §7.3 Own IOVV (Input/Output/Verification/Validation) traceability tables and ensure design outputs map cleanly to design inputs Support design reviews, prepare review packages, and track action items to closure Draft and execute verification and validation protocols and reports (tensile strength, needle attachment, packaging integrity, etc.) Risk Management Maintain risk management files per

ISO 14971

2019 — hazard analysis, risk assessment, FMEA (design and process), and risk management reports Facilitate risk assessment sessions with cross-functional teams (engineering, operations, quality) Track residual risk acceptability and support benefit-risk analyses where required Regulatory Affairs Support 510(k) submission preparation, including predicate device comparisons and substantial equivalence arguments Maintain awareness of applicable standards (USP suture requirements, ISO 10993 biocompatibility, ISO 11135/11137 sterilization) and flag gaps Assist with responses to FDA correspondence and pre-submission meetings Quality System Maintenance Author, revise, and maintain Quality System Procedures (QSPs) and associated forms Support internal audits, supplier audits, and management review Own or support CAPA investigations, complaint handling, and nonconformance dispositioning Maintain calibration, training, and document control records Product/Process Support Collaborate with manufacturing on process validation (IQ/OQ/PQ) for braiding, cutting, needle attachment, and packaging processes Support statistical sampling plans and acceptance criteria for incoming, in-process, and final inspection Participate in new suture line development from a quality/regulatory perspective — reviewing drawings, specifications, and manufacturing processes for design control compliance What You Bring Required Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field Working knowledge of 21 CFR 820 (QMSR), ISO 13485:2016, and

ISO 14971

2019 Experience with design controls, risk management, and DHF documentation Strong technical writing skills — you can turn ambiguous requirements into clear, defensible documentation Comfortable in Excel (data analysis, basic formulas) and Word for document generation Preferred 2+ years of quality engineering experience in a regulated medical device environment (Class I/II preferred) Direct experience with 510(k) submissions or FDA interactions Familiarity with suture, textile, or braided-product manufacturing Experience with statistical techniques (sampling plans, process capability/Cpk) Exposure to sterilization validation (EO, ISO 11135) or packaging validation (ISO 11607) Experience with electronic QMS/document control platforms (e.g., Cognidox, MasterControl, Greenlight Guru) What Success Looks Like DHFs are complete, internally consistent, and audit-ready at any point in the design cycle Risk files accurately reflect the current state of the device and are updated as design or process changes occur 510(k) submissions move through internal review efficiently, with minimal rework from missing traceability or unclear rationale Quality system documentation stays current without becoming a bottleneck to product development

Job Type:

Full-time Pay:

$75,000.00 - $85,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Retirement plan Vision insurance Ability to

Commute:

Millersville, MD 21108 (Required)

Work Location:

In person