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Planet Pharma

Quality Engineer I

Planet Pharma, North Haven, Connecticut, us, 06473

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Quality Engineer I - Planet Pharma

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Quality Engineer I

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Planet Pharma . This entry‑level position supports the design quality team for Sutures & Polymers, ensuring design, process, manufacturing, or supplier changes meet existing quality and reliability standards. Team

Direct team: 5 engineers ranging from Quality Engineer I to Principal Quality Engineer. Cross‑functional: Collaboration with PMs, R&D, and manufacturing. Responsibilities

Assess design/manufacturing/process/supplier changes. Review validation/verification documentation and provide feedback. Perform Design Failure Modes Effect Analysis (DFMEA). Complete risk assessments for proposed changes. Perform/support root cause analysis for product complaints. Develop, modify, apply and maintain quality standards and protocols for processing materials. Collaborate with engineering and manufacturing to ensure quality standards. Devise and implement methods and procedures for inspecting, testing, evaluating precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; perform statistical analysis to assess cost and responsibility for non‑conforming products or materials. Ensure corrective measures meet reliability standards and documentation complies with requirements. May specialise in areas such as design, incoming material, production control, product evaluation, reliability, inventory control, and research & development. Qualifications

0‑2 years of experience. Must‑have skills: Communication, attention to detail, technical writing, critical thinking. Nice‑to‑have skills: Statistics, validation/verification knowledge, risk analysis, FMEA, root cause analysis experience. Work hours: approximately 9 am – 5 pm. Employer

The Planet Group of Companies is an equal‑opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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