Quality Engineer at Spencer Health Solutions (Morrisville, NC)

The Quality Engineer is responsible for maintaining regulatory and quality management system requirements as it relates to product development and product lifecycle management.  The Quality Engineer is an active participant and problem solver that can easily transition between different functional teams to meet ambitious timelines.

Qualifications

• Lead Quality and Regulatory activities in preparation for product launches and updates


• Develop engineering and regulatory requirements for new products in the medical and clinical markets


• Manage the product risk management file and lead product risk management activities


• Manage product validation activities including developing product validation test strategies and reports


• Support design transfer activities and supplier qualifications


• Support the defect and nonconforming material processes


• Responsible for supporting product complaint investigations, corrective action implementation, and effectiveness checks


• Initiate, review, and approve change controls


• Advise Engineering and Marketing on labeling requirements and marketing materials


• Lead activities related to internal CAPA’s, department objectives, and company initiatives

REQUIREMENTS

• BS/MS in Engineering or equivalent technical degree.


• 5+ years of medical device management experience.


• Knowledge of 21CFR820, SOR/98-282, MDR 2017/745, HIPAA, and GDPR


• Experience with ISO 13485, MDSAP, ISO14971, IEC 62304, IEC 60601


• Experience using statistical analysis tools and developing sampling plans


• Familiarity with IT and wireless technologies a plus


• Familiarity with the clinical trial process a plus


• Ability to analyze and interpret standards and government guidance and regulation documents


• Ability to write standard operating procedures, work instructions, specifications, and technical reports


• Ability to effectively communicate company status, goals, and initiatives throughout the organization

Additional information

Spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class.

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