Sr. Product Quality Engineer (V&V)
Katalyst CRO • Atlanta, Georgia, United States
Role & seniority: Senior Product Quality Engineer; technical representative; leads and/or supports risk management team; cross-functional collaborator focused on development quality for medical devices
Stack/tools: Design Control, risk management processes (FMEA, risk docs); test method development/validation; quality systems (QMS/EMS); DOORS (preferred); JIRA (preferred); statistics for V&V
Top 3 responsibilities
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Lead and/or support on-time completion of Design Control deliverables and establish objective product requirements
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Lead Risk Management activities from concept through commercialization; plan/execute Design Verification and Validation and cross-functional investigations
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Support manufacturing process development/qualification, component specifications, supplier qualifications, biocompatibility/sterilization qualifications, audits, and quality-system improvements
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Must-have skills: Bachelor's degree in engineering/technical field; ≥5 years in R&D/Process/Manufacturing Engineering and/or Quality with ≥2 years in product development; medical device experience with relevant regulations/standards; test method development/validation; experience preparing risk assessments and FMEA
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Nice-to-haves: Advanced engineering/technical degree; experience with active implantable medical devices; knowledge of requirements management tools (DOORS) and issue tracking (JIRA); working knowledge of statistics applied to V&V
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Location & work type: Location not speci
Full Description
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.
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 ".
