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Sr Quality Engineer

Sr Quality Engineer

Katalyst Healthcares & Life Sciences

Hathorne, MA

$94.20K - $127.70K/yr

Other

Posted 2 days ago

Job description

Responsibilities:
  • Provide Quality Engineering support for commercial medical device products.
  • Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
  • Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
  • Able to present quality during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation Present technical data to groups within and outside the organization.
  • Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
Requirements:
  • Medical Device Design & Development.
  • Risk Management: dFMEA, pFMEA, Statistical analysis.
  • Technical Writing: IQs, PQs, TMVs.
  • Hands on experience on upstream new product development vs downstream manufacturing transfer and operations quality.
  • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016.
  • Demonstrated working knowledge of process validation, statistical methods, risk management.
  • Green Belt Six Sigma/DRM Training/Certification is preferred, but not required.
  • ASQ-CQE, CQA, CBA or equivalent certifications preferred, but not required.
  • SAP QM or SPC Software experience preferred, but not required.
  • Bachelor's Degree in Engineering, Science or technical field AND 5-7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality.
  • In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.
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About Katalyst Healthcares & Life Sciences

Sourced by ZipRecruiter

Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Senior Quality Engineer?

A: To succeed as a Senior Quality Engineer, key technical skills include expertise in quality management systems (e.g., ISO 9001), statistical process control (e.g., Six Sigma, Lean), and software testing methodologies (e.g., Agile, DevOps). Soft skills such as effective communication, problem-solving, and leadership abilities are also crucial, as Senior Quality Engineers often mentor junior team members and collaborate with cross-functional teams to drive quality improvements. By combining these technical and soft skills, Senior Quality Engineers can drive quality excellence, reduce defects, and contribute to the overall success of their organization, positioning themselves for career advancement and leadership opportunities.

Q: What is the career path for a Senior Quality Engineer?

A: A Senior Quality Engineer's typical career progression involves starting as a Quality Engineer or Quality Assurance Engineer, then advancing to a Lead Quality Engineer or Quality Manager role, and finally, becoming a Senior Quality Engineer or Director of Quality. Key opportunities for skill development and professional growth include developing expertise in quality management systems, risk management, and statistical process control, as well as staying up-to-date with industry regulations and standards. Long-term career prospects for Senior Quality Engineers may include transitioning into leadership roles, such as Director of Quality or Vice President of Quality, or pursuing specialized roles like Quality Consultant or Auditor.

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Katalyst Healthcares & Life Sciences job posting for a Sr Quality Engineer in Hathorne, MA with a salary of $94,200 to $127,700 Annually with a map of Hathorne location.