Sr. Product Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Job Description:

• The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team.
• Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.
• This individual will be leading and managing a risk management team but could also work on other items. Looking for someone well rounded from a development quality perspective.

Roles & Responsibilities:

• Lead and/or support on-time completion of Design Control deliverables.
• Support the establishment of objective, measurable, and verifiable product requirements.
• Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities.
• Lead Risk Management activities from product concept through commercialization.
• Support test method development and lead test method validation activities.
• Support manufacturing process development & qualification for new product and design changes.
• Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications.
• Support biocompatibility and sterilization qualifications.
• Support audits and quality system improvement activities.
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Comply with Client, U.S. FDA, EUMDR and other requirements, as applicable.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Requirements:

• Bachelor's degree in engineering or Technical Field.
• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
• Experience in medical devices and associated regulations/standards.
• Experience in test method development and validation.
• Experience in preparing risk assessments, FMEA and other risk documents.

Preferred Qualifications:

• Advanced Degree in Engineering/Technical Field.
• Experience in active implantable medical devices.
• Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation.

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