Quality Engineer - FDA Remediation, CAPA & RCA
Fusion Life Sciences technologies LLC
Fusion Life Sciences Technologies LLC seeks a Quality Engineer for a 6-month contract in Marlborough, MA. You will own deviations, perform RCA, and drive CAPA through closure while collaborating across Manufacturing, Quality, Engineering, Validation, and Operations. The role requires 5+ years in the medical-device space with strong knowledge of FDA requirements and QMS. Hands-on problem-solving, documentation, and cross-functional teamwork are essential as you support remediation efforts. #J-18808-Ljbffr Fusion Life Sciences technologies LLC
- ...leader in womens health, seeks a Sr. Product Quality Engineer to ensure the reliability of life-saving... .... You will lead investigations, drive CAPA, and mentor junior engineers in a... ...manage risk, and ensure compliance with FDA QSR and ISO 13485. The position offers competitive...Suggested
$40 - $45 per hour
...this job is worth considering This Quality Engineer opening supports FDA remediation work inside a regulated medical-... ..., run root cause analysis, and own CAPA activities through closure, while partnering... ...detailed root cause analysis (RCA) and identify systemic and...SuggestedHourly payContract workFor contractorsWorldwide$110k - $140k
...everything possible. The Senior Supplier Quality Engineer is responsible for applying a... ...feedback and collaborative support on RCA with suppliers for all SCAR types including... ...manage annual supplier audit planning. Lead remediation activities due to failed audit.Execute...SuggestedHourly payFull time- Scorpion Therapeutics is seeking a Lead Quality Engineering Product Surveillance to elevate product quality in a biopharma manufacturing setting. You will investigate issues, drive CAPA, and partner with Engineering, Manufacturing, and Customer teams to resolve complex...Suggested
- ...Spencer Gregory HaleSenior Cybersecurity Quality Systems Engineer About the role The Senior Cybersecurity... ...activities, regulatory inspections, CAPA investigations, and quality improvement... ...risk management. Working knowledge of FDA medical device cybersecurity guidance,...SuggestedHourly payShift work
- Recruiter: Spencer Gregory HaleSupplier Quality Engineer II - Endoscopy SFMD About the role: The Sourced Finished Medical Device (SFMD) Supplier... ...in process validation, design controls, risk management, and CAPA. Lead auditor of quality systems experience (ISO 13485 or...Hourly payShift work
- ...Supplier Quality Engineer Marlborough, MA Long Term Contract Supplier Quality Engineer is needed to assist our client with their... ...• UDI and medical device labelling/marking, quality system remediation, and ability to positively interfacing with the company's suppliers...Long term contract
- ...The Senior Supplier Quality Engineer is responsible for ensuring suppliers meet Repligen quality... ...audits, nonconformance investigations, CAPA/SCAR, and root cause analysis. ~ Working... ...regulatory requirements, including GMP and FDA requirements. ~ Ability to evaluate...
$85k - $145k
...Senior Quality Engineer $85000 - $145000 per year | Marlborough, MA | On-site | Permanent Quality Engineering role supporting cutting edge... ...: # Develop and implement the quality plan, including CAPA, non-conformances, and corrective actions. # Collect, analyze...Permanent employmentLocal area$80k - $85k
...SUMMARY TekniPlex is hiring a Quality Engineer for our Ashland, MA facility.... ...management, nonconformances, CAPA/corrective actions, document... ...9001, GMP, and applicable FDA/21 CFR requirements. Plan,... ...translate findings into effective remediation and improvement actions. ~...Daily paidTemporary workFor contractorsLocal areaImmediate startFlexible hoursShift work$64.35k - $93.17k
...and do things right Support all Quality activities of a high-volume... ...plant, including: MRB support CAPA management Complaint investigation... ...and tools.As an entry level engineer, you will ensurethatInteger's... ...Food and Drug Administration (FDA) regulations, company policies...Immediate startWorldwide$86.8k - $165.2k
...than 100 years of experience and renowned engineering expertise to meet the needs of today’s... ...defense.Join our team as a Hardware Program Quality Engineer (PQE) supporting the Upper Tier... ...experience to support root cause analysis (RCA), corrective actions, and closed-loop...Temporary workWork experience placementWork at officeRemote workRelocationFlexible hours- ...passionate about ensuring the quality and reliability of life-saving... ...seeking a Sr. Product Quality Engineer to provide engineering support... ...Knowledge:Strong understanding of FDA Quality System Regulations,... ..., root cause analyses, and CAPA activities to resolve quality...Worldwide
- ...daily lives. As a Software DQA Engineer, you’ll be at the heart of... ...company widely regarded as being a quality leader in the medical device... ...the requirements of EN 62304, FDA guidance documents and internal... ...applicability of NCEP/CAPA process on design changes.Create...Hourly payWork at officeRelocation packageShift work3 days per week
- ...ambitions. About the Role: The Design Quality Assurance Engineer III provides quality engineering support... ...of complaints, nonconformances, CAPAs, product investigation reports, audit... ...device standards compliance. Knowledge of FDA Quality System Regulations, ISO 13485,...Hourly payRelocation packageShift work3 days per week
- ...’re looking for a Lead Risk Management Quality Engineer to ensure the safety and compliance of... ...risk requirements.Strong understanding of FDA Quality System Regulations (21 CFR Part... ...risk management activities and remediation projects.Experience developing and improving...
- Boston Scientific is seeking a Supplier Quality Engineer II for the Endoscopy SFMD team in Massachusetts. You will collaborate with suppliers... ...Responsibilities include sustaining engineering, supplier audits, CAPA and change control, new product development support, and...
$85k - $115k
...wages and PTO, plus our benefits begin on day 1 of employment. Come join a workforce where we put you first!Job Summary: The Quality Engineer plans, coordinates, and executes quality engineering activities that ensure products and manufacturing processes meet customer...Full timeFor contractorsWork at officeWeekend work$86.8k - $165.2k
...aerospace and defense.Collins Connected Aviation - Air Traffic Systems (ATS) organization has an immediate need for a Senior Quality Engineer within our ATS team. As a Senior Quality Engineer, you will work collaboratively with other engineers in the design, development...Contract workTemporary workWork experience placementWork at officeImmediate startRemote workRelocation packageFlexible hours$84k - $110k
...~ Health insurance ~ Paid time off Position Title Quality Engineer II – Supports assigned customers to assure best‑in‑class quality... ...determine root cause of customer issues, Complaints, and CAPAs using various techniques including but not limited to Reenactment...Work at office- ...Job Description We are seeking a highly motivated Quality Engineer to lead and manage advance quality control activities for new product launches. As a Quality Engineer, you will be responsible for ensuring that the quality system is in place to assure ongoing compliance...
- ...skills and career. Here, you’ll be supported in progressing - whatever your ambitions. About this role:The Senior Design Quality Assurance Engineer will provide direct DQA support to a team focused on solving complex technical challenges across the Endoscopy portfolio...Hourly payImmediate startRelocation packageShift work3 days per week
- ...Type: C2CIndustry: Computer SoftwareClient: WiproContact: Prudhvi Surabhi, Putla BharathCompany: SRI Tech SolutionsJob Role : QA Engineering architectJob Location : Marlborough , MA Onsitewe are looking for a strong technical person with extensive experience with Test automation...
$80k - $100k
...across four advanced U.S. facilities, we operate at a level where quality directly impacts customer success, long-term partnerships, and... ...need a quality leader who can keep pace. Position: Quality Engineer (Plastic Injection Molding) Location: Hudson, MA (on-site)...Full timeContract workTemporary workLocal areaMonday to FridayFlexible hours$100.26k - $135.36k
...Supplier Qualifications, Audits, Quality Assurance Agreement... ...Olympus. Qualifies new and remediate qualifications of existing suppliers... ...by outside agencies (i.e., FDA, ISO/ MDSAP / ISP / ANVISA /... ...escalation path for supplier quality engineering part-level concerns. Job...Full timeWork at officeLocal areaWorldwide- Position SummaryThe Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics... ...and risk management.Deep working knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.Proven experience...
$82.1k
...Recruiter: Spencer Gregory Hale Quality Systems Engineer III About the role: The Quality Systems Engineer III supports the Global... ...improve overall system effectiveness. Quality events, CAPA and risk management Serve as an owner or contributor for...Hourly payPermanent employmentWork at officeLocal areaRelocationRelocation packageShift work3 days per week- Boston Scientific Marlborough, MA is seeking a Senior Cybersecurity Quality Systems Engineer to join the Global Software Quality organization. You will serve as the Quality Systems SME for cybersecurity of medical devices, reviewing documentation to ensure alignment with...
- ...Our client is currently seeking a Senior Design Quality Engineer .This a full-time permanent role with competitive salary + bonus and benefits... ...-mechanical medical devices. ~ Experience working within FDA-regulated and ISO-compliant medical device environments....Permanent employmentFull time
- ...Location: Onsite: Boston, MA Position Overview The organization is seeking an experienced QA Automation Engineer to lead and advance its Quality Assurance Automation initiative. This role will focus on designing, evaluating, implementing, and maintaining scalable...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Engineer - FDA Remediation, CAPA & RCA. Be the first to apply!
- quality systems engineer Marlborough, MA
- supplier quality engineer Marlborough, MA
- senior quality engineer Marlborough, MA
- quality engineer Marlborough, MA
- quality assurance quality control engineer Marlborough, MA
- advanced quality engineer Marlborough, MA
- senior manager quality engineering Marlborough, MA
- senior supplier quality engineer Marlborough, MA
- senior quality systems engineer Marlborough, MA
- senior data quality engineer Marlborough, MA



