| Job alert | Jobs 1 - 10 of 284 |
Engineer II/DHF
Enhanced Compliance Inc.
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Marlborough, MA, 01752
... Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities. Identify industry best practices. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Ensure that required standards for ... - May 02
Sr. Design Quality Assurance Engineer
Enhanced Compliance Inc.
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Massachusetts
... Must have a good understanding of FDA 21CFR820, ISO 13485, 14971, and 11607 standards. Strong engineering, design, and analysis skills. Working knowledge of tooling and manufacturing processes. Experience with medical devices from concept to ... - Apr 28
Mechanical Engineer II
CEI Group
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Ayer, MA, 01432
... Preferred Knowledge of relevant industry standards (ASME BPE, USP VI, FDA, PED (EU), cGMP, BPOG) is a significant plus - Apr 26
Associate Director, Plant Quality Assurance
Replimune, Inc.
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Framingham, MA
... Ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies where Replimune clinical or commercial products are in use. Responsible for the evaluation and assurance that the validation of the ... - Apr 18
Engineering Consultant I
Enhanced Compliance Inc.
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Massachusetts
... Ensures proper documentation is completed to meet US FDA 21 CFR 820, EUMDR, ISO 13485, and other applicable international regulations and standards. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, ... - Apr 18
Regulatory Affairs Consultant
Connect Life Science
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Massachusetts
... Responsibilities: Provide guidance and support to cross-functional teams in the interpretation and implementation of regulatory requirements, standards, and guidelines (e.g., FDA, EU MDR, ISO 13485). Work with R&D to ensure regulatory compliance is ... - May 02
Medical Device Software Quality Engineer
VulcanForms
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Devens, MA, 01434
... system processes or critical business functions, in accordance with current applicable standards and regulations (including FDA 21 CFR Part 11, FDA General Principles of Software Validation and ISO 13485) Manage and maintain non-product software ... - Apr 18
R&D/DHF Engineers
Enhanced Compliance Inc.
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Massachusetts
... Understanding of FDA Quality Systems Regulations. Note: Third party resumes will not be accepted for this role. This role will be require support on site in the Massachusetts area. - Apr 28
Medical Device Product Manager
Exergen Corporation
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Watertown, MA, 02472
... Required Education and Experience: · 8+ years of experience working in an FDA/ISO regulated medical device/medical equipment environment. · 5+ years of experience preferred managing technical teams and programs. · Detail oriented with strong ... - Apr 28
Senior Quality Systems Engineer
Discover International
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Massachusetts
... Strong knowledge of GMP, FDA regulations, ISO 13485. Skilled in deviation, nonconformance, CAPA, and complaint handling. Familiarity with electronic document management systems. Works independently with minimal supervision. Adaptable to fast-paced ... - May 02