6 Month Contract M-F onsite Job Overview We are seeking a highly experienced Senior Quality Engineer with 12+ years of experience in the medical device industry. The ideal candidate will have a strong background in process engineering, process validation, change management, complaint management, and Corrective and Preventive Actions (CAPA). We are particularly interested in candidates who have previously worked with our organization and demonstrated strong performance. Local candidates are preferred. Relocation may be considered for exceptional, proven candidates, subject to the availability of relocation expense reimbursement. Key Responsibilities Lead and support process engineering activities to ensure product quality, process consistency, and compliance with applicable medical device regulations and quality system requirements. Develop, write, review, and execute process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Manage process changes, including impact assessments, risk evaluations, documentation, and implementation in accordance with established quality procedures. Support complaint management activities, including investigation, root cause analysis, documentation, and timely resolution. Lead and support Corrective and Preventive Action (CAPA) activities, ensuring effective root cause identification, corrective action implementation, and effectiveness verification. Maintain accurate and compliant quality documentation and validation records. Collaborate cross-functionally with Manufacturing, Engineering, Quality, and Regulatory teams to resolve quality issues and drive continuous improvement. Ensure compliance with applicable medical device industry standards, regulatory requirements, and internal quality management system procedures. Required Qualifications Bachelor's degree in Engineering or a related technical field. 12+ years of relevant Quality Engineering experience, preferably within the medical device industry. Strong experience in process engineering and process validation. Demonstrated experience writing and executing

IQ/OQ/PQ

protocols. Hands-on experience with process changes and change control. Experience managing product complaints and conducting investigations. Proven experience with CAPA processes, root cause analysis, and corrective action effectiveness checks. Strong technical writing, documentation, problem-solving, and cross-functional communication skills. 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

GRPB Pay:

$70.00 - $80.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance People with a criminal record are encouraged to apply

Work Location:

In person