Sr. Quality EngineerKatalyst Healthcares and Life Sciences • Boston, MA, United States
[error_messages.no_longer_accepting]
Sr. Quality Engineer
Katalyst Healthcares and Life Sciences • Boston, MA, United States
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]M.S. in Engineering with 3+ years, or B.S. with 5+ years of experience. 2-5 years in a regulated medical device environment; experience with combination products preferred. Knowledge of ISO 13485, ISO 14971, 21 CFR 820, and cGxP principles. Experience with DHF management, risk management, and lifecycle management. Strong statistical, technical writing, and communication skills. bility to work independently, manage multiple projects, and collaborate effectively with cross-functional teams.
Responsibilities :
- Ensure design control compliance and maintain Design History Files (DHF) for new product development.
- Review and approve design documentation, risk analyses (dFMEA, uFMEA, pFMEA), and verification / validation protocols.
- Support change control, impact assessments, and DHF updates.
- Investigate product complaints, lead root cause analyses, and support corrective actions.
- Evaluate product designs for manufacturability, reliability, biocompatibility, and compliance.
- Contribute to new product commercialization and continuous improvement initiatives.
- Support vendor management, audits, and documentation for product release.
Requirements :
[job_alerts.create_a_job]
Sr Quality Engineer • Boston, MA, United States
[internal_linking.related_jobs]
Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform.
With only five minutes of wear-time on the skin, the self-applied...[show_more]
Contract Opportunity Quality Engineer (Edifecs Project).Collaborate with technical and business teams to ensure data accuracy and functional integrity.
Demonstrated experience creating and executin...[show_more]
Title : Senior Validation Engineer.Location : Boston, MA (on-site).A growing biotech company working on regenerative medicine is looking for a.
If you're experienced in GMP biotech environments and en...[show_more]
Amphenol Pcd is seeking a Senior Quality Engineer to join our team in Beverly, MA.The Senior QE plays a pivotal role in ensuring rapid response and resolution of Continuous Improvement opportunitie...[show_more]
Responsibilities may include the following and other duties may be assigned.Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families.Acco...[show_more]
Overview The InterSystems IRIS Data Platform is the foundation for industry-leading applications with demanding scalability, resilience, and high availability requirements.Quality Development helps...[show_more]
The Middlesex Corporation is a nationally recognized and award-winning leader in the heavy civil construction industry.Since 1972, the family business founded by Robert W.Pereira has developed an e...[show_more]
At Johnson & Johnsonwe believe health is everything.Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are ...[show_more]
Saviynt's AI-powered identity platform manages and governs human and non-human access to all of an organization's applications, data, and business processes.
Customers trust Saviynt to safeguard the...[show_more]
Unleash the Power of Multi-Mission Excellence : Safeguarding the Seas for the Worlds Navies.Step into a world where cutting-edge technology meets unparalleled expertise.
Ultra Maritime pioneers deliv...[show_more]
Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of delivering ...[show_more]
Engineer for Kinaxis will be responsible for Kinaxis Rapid Response system administration and support designing, developing, and implementing innovative supply chain solutions using the Rapid Respo...[show_more]
Xico Lighting is a rapidly growing manufacturer of spec-grade architectural lighting, driven by precision, performance, and design excellence.
As we expand our in-house manufacturing and engineering...[show_more]
Draper is an independent nonprofit research and development company headquartered in Cambridge MA.The 2000 employees of Draper tackle important national challenges with a promise of delivering succ...[show_more]
Data Management solution provider focused on Data Operations services for enterprise data in the cloud.We are leading the innovation agenda with our clients by delivering a portfolio of services to...[show_more]
Specialist, Quality Operations.Be Biopharma ("Be Bio") is pioneering Engineered B Cell Medicines (BCM) to dramatically improve patients' lives who are living with cancer, rare diseases and other se...[show_more]
Founded on a commitment to relentless, continuous operational improvement and extraordinary customer service, we at Pursuit Aerospace pride ourselves on competitive cost structures, exceptional on-...[show_more]
Saviynt's AI-powered identity platform manages and governs human and non-human access to all of an organization's applications, data, and business processes.
Customers trust Saviynt to safeguard the...[show_more]
Quality System Specialist / Senior Quality System Specialist
Vaxess Technologies • Woburn, MA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Engineer (Edifecs Project) (Boston)
JCW Group • Boston, MA, United States
[job_card.temporary]
[last_updated.last_updated_variable_days] • [promoted]
Sr. Validation Engineer (Cambridge)
EPM Scientific • Cambridge, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Senior Quality Engineer
Amphenol Pcd • Beverly, MA, United States
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Principal Quality Engineer - Post Market Risk
Medtronic • Boston, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Principal Quality Development Engineer
InterSystems • Boston, MA, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Control Manager
The Middlesex Corporation • Boston, MA, United States
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Senior Quality Engineer
Johnson & Johnson • Raynham, Massachusetts, USA
[job_card.full_time]
[last_updated.last_updated_variable_hours] • [promoted] • [new]
Sr. Solutions Engineer
Saviynt Inc. • Boston, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Supplier Quality Engineer
Ultra • Braintree, Massachusetts, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Senior Component Quality Engineer
Draper Labs • Cambridge, MA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Sr. Kinaxis Engineer
Boston Beer Corporation • Boston, MA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Engineer
Xico Lighting • Woburn, Massachusetts, United States
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Component Quality Engineer II
The Charles Stark Draper Laboratory • Cambridge, Massachusetts, USA
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Systems Engineer (Medical Devices Industry) @ Andover, MA
NextPhase.ai • Andover, MA, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Contract - Sr. Specialist, Quality Operations
Be Biopharma • Cambridge, MA, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Inspector
Pursuit Aerospace • Newburyport, MA, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Sr. Solutions Engineer
Saviynt • Boston, Massachusetts, United States, 02108
[job_card.full_time]
[last_updated.last_updated_variable_days]