- Support validations for new and existing products, processes and equipment.
- Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure.
- Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc...
- Manage and support batch record review and disposition of product.
- Support and prepare for site-level internal, external, supplier and customer audits.
- Apply systematic problem-solving methodologies and provide quality support to identify and resolve quality issues to ensure production of safe and effective medical devices.
- Identify and implement opportunities for continuous improvement.
- Interact and coordinate activities with other departments, external vendors and customers.
- Perform other Quality System related duties as required.
- Non conformance, Capa, ISO 13485, FDA, validation, audit, risk management, pFMEAS, batch record review, continuous improvement, bachelors degree, quality engineering, GMP, medical device, process engineering, IQ, OQ, PQ, external audit, internal audit, customer identity, QMS
- Nonconformance, Capa, ISO 13485,FDA,validation,audit,risk management, pFMEAS, batch record review, continuous improvement, bachelor's degree, quality engineering, GMP, medical device
- Bachelors degree required, preferably in Engineering, Science (Chemistry, Biology, Physics, etc) or Math (Statistics).
- 5+ years of experience in roles with increasing levels of complexity and scope.
- Experience in an FDA regulated manufacturing or industrial environment.
- Strong working knowledge of FDA / ISO 13485 Quality System. requirements, GxP, and other relevant standards and regulations.
- Technical skills and experience related to process validation, statistical methods, and risk management.
- Experience performing quality audits. Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred.
- Lean manufacturing / Six Sigma helpul
- Strong cross-collaborator, effective coaching and mentoring skills
- Ability to work independently, well organized and self-driven.
- Excellent written and verbal communication skills.
- Experience Level:* looking for 3-5 years of experience
-
Quality Engineer
2 weeks ago
INTELLECTT INC Burlington, United StatesRole: Engineer · Location: Burlington, MA · Duration: 6 Months · Shift Timings: 8 AM to 5 PM · Main Purpose Of Role · Perform failure analysis on explanted biomedical implant product. Provide technical expertise to the product Analysis Laboratory. Analyzes failures, develops ...
-
Senior Quality Engineer
3 weeks ago
restor3d Wilmington, United StatesJob Description · Job DescriptionJob Summary: · The Senior Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits. · Essential Duties ...
-
Quality Engineer
6 days ago
Randstad North Billerica, United StatesJob Summary: · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collabora ...
-
Quality Engineer
3 weeks ago
Servomex Woburn, United StatesServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Quality Engineer to join our high performing team at our site in Woburn, MA. · The successful candidate will work closely with our manufacturing teams at our U ...
-
Quality Engineer
2 weeks ago
SUMERU INC Westborough, United States**Key Responsibilities**: · - Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records. · - Writes and reviews tec ...
-
Quality Engineer
3 weeks ago
Randstad USA Billerica, United StatesJob Summary · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collaborat ...
-
Quality Engineer
1 week ago
Randstad USA North Billerica, United States Full timejob summary: · Our client north of Boston is looking for a Quality Engineer to join their growing team This is a great opportunity for someone who is looking for a team oriented environment. Our client is very focused on working together to complete projects using cross collabora ...
-
Quality Engineer
3 weeks ago
Spectra Medical Devices Wilmington, United StatesJob DescriptionJob Description · POSITION SUMMARY: · The desired candidate will have prior experience working as a Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to, providing Quality and ...
-
Senior Quality Engineer
3 weeks ago
Imaginary Burlington, United StatesPosition Introduction: · 10Beauty is seeking a Senior Quality Engineer who will play a crucial role in owning and ensuring the highest standards of quality throughout our organization. This position requires a strategic thinker with a deep understanding of change control process ...
-
Quality Engineer
1 week ago
Spectrum Industries Cambridge, United StatesDigital transformation. Sustainability. Peacekeeping. Exciting tasks that we at Diehl, in our five subgroups Metall, Controls, Defence, Aviation, and Metering, and our over employees are working on with high pressure. Discover fascinating technologies and apply now. In a family-o ...
-
Software Quality Assurance Engineer
6 hours ago
Symbotic Wilmington, United StatesWho we are · With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased effici ...
-
Site Quality Engineering Manager
3 weeks ago
Lockheed Martin Andover, United States**Job ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**:Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Massach ...
-
Site Quality Engineering Manager
3 weeks ago
Lockheed Martin Corporation Andover, United States**JOB ID**: 665892BR · **Date posted**: May. 09, 2024 · **Description**: · Lockheed Martin is seeking an experienced, highly motivated Quality Engineering Manager to lead the Quality Assurance organization at Lockheed Martin's cutting-edge Energy operations based in Andover, Mass ...
-
Quality Engineer
1 week ago
Velocity Solutions North Walpole, United StatesAbout the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
-
quality engineer
1 week ago
Randstad North Billerica, United Statesquality engineer. · north billerica , massachusetts · posted 3 days ago · job details · summary · $70,000 - $85,000 per year · permanent · bachelor degree · category computer and mathematical occupations · reference · job details · job summary: · Our client north of Boston ...
-
quality engineer
1 week ago
Randstad North Billerica, United Statesquality engineer. · north billerica , massachusetts · posted 2 days ago · job details · summary · $70,000 - $85,000 per year · permanent · bachelor degree · category computer and mathematical occupations · reference · job details · job summary: · Our client north of Boston ...
-
Quality Engineer
2 weeks ago
Precision Life Sciences Burlington, United StatesJob Description: Quality Engineer · The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. · RESPONSIBILITIES · Support sustaining engineering through ...
-
Quality Engineer
3 weeks ago
Precision Life Sciences Burlington, United StatesJob Description: Quality Engineer · The Quality Engineer will support sustaining engineering and new product development activity for the Quality Assurance department in a dynamic and complex engineering environment. · RESPONSIBILITIES · Support sustaining engineering through ope ...
-
Quality Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Burlington, United StatesResponsibilities: Perform failure analysis on explanted long-term biomedical implant product. · Work requires the application of theoretical principals, evaluation, ingenuity, and creative/analytical. · Must be able to meet deadlines on multiple assignments and be able to oper ...
-
Quality Engineering Technician
1 week ago
Pursuit Aerospace Malden, United States**Quality Engineering Technician** · Malden, MA, US · **About Pursuit Aerospace** · Pursuit Aerospace is the largest privately held aerospace manufacturers in the world. We are a global manufacturer of complex aircraft engine components that are developed through highly integrate ...
Senior Quality Engineer - Wilmington, United States - Katalyst Healthcares and Life Sciences
