Find & Apply For Validation Engineer Jobs in Powhatan, North Carolina

Senior Quality Engineer - Medical DeviceJob Summary We are seeking an experienced Senior Quality Engineer with a strong background in the medical device industry to support manufacturing quality, process engineering, validation, and quality system initiatives. The ideal candidate will have extensive experience driving process improvements, managing product and process changes, executing validation activities, and resolving quality issues in a regulated manufacturing environment. This is a senior-level position requiring at least 12 years of relevant experience and a strong understanding of medical device quality systems and regulatory requirements. Key Responsibilities Lead quality engineering and process engineering activities within a medical device manufacturing environment. Develop, write, review, and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Support process validation, equipment qualification, and ongoing process monitoring to ensure manufacturing processes remain capable and compliant. Evaluate, implement, and document manufacturing process changes in accordance with established change control procedures. Investigate product and process quality issues, perform root cause analysis, and implement effective corrective and preventive actions (CAPA). Manage customer complaints and support complaint investigations, ensuring timely resolution and appropriate documentation. Collaborate with Manufacturing, Process Engineering, Quality Assurance, and other cross-functional teams to address quality concerns and improve manufacturing performance. Ensure compliance with applicable medical device regulations, quality standards, and internal procedures. Maintain accurate quality documentation, validation records, investigation reports, and change control documentation. Identify opportunities for continuous improvement in manufacturing processes, product quality, and quality system effectiveness. Provide technical guidance and quality engineering expertise to support manufacturing operations and regulatory compliance. Required Qualifications Bachelor's degree in Engineering or a related technical field. At least 12 years of relevant Quality Engineering or Process Engineering experience. Direct experience working within the medical device industry. Strong background in manufacturing processes and process engineering. Hands-on experience writing and executing

IQ/OQ/PQ

validation protocols. Experience managing process changes and formal change control activities. Experience with complaint management, investigations, root cause analysis, and CAPA. Strong understanding of quality systems and regulatory requirements applicable to medical device manufacturing. Excellent technical writing, documentation, problem-solving, and cross-functional communication skills. Preferred Qualifications Experience supporting regulated medical device manufacturing operations. Experience with process validation, equipment qualification, and manufacturing process improvements. Familiarity with FDA quality system requirements and

ISO 13485.

Previous experience working successfully within the organization or in a similar manufacturing environment. #GRPA Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.

Pay:

$70.00 - $80.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Vision insurance

Work Location:

In person