Senior Quality Engineer -

Medical Devices Location:

TBD Position Type:

Full-Time Experience Required:

12+

Years Education:

Bachelor's Degree Required Position Summary We are seeking a highly experienced Senior Quality Engineer with a strong background in the medical device industry to support manufacturing quality, process engineering, validation, and continuous improvement initiatives. The ideal candidate will have at least 12 years of relevant experience in a regulated medical device manufacturing environment, with demonstrated expertise in process validation, developing and executing

IQ/OQ/PQ

protocols, managing process changes, investigating product complaints, and driving Corrective and Preventive Actions (CAPA). This position requires a hands-on quality engineering professional capable of independently managing complex quality initiatives, collaborating with cross-functional teams, and ensuring manufacturing processes consistently meet regulatory requirements and quality standards. Key Responsibilities Process Validation & Engineering Develop, author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Lead process validation activities for new and existing manufacturing processes, equipment, and systems. Support process engineering initiatives to improve manufacturing efficiency, product quality, and process reliability. Evaluate and implement manufacturing process changes while ensuring compliance with established quality requirements. Prepare validation reports, technical documentation, and supporting quality records. Partner with Manufacturing, Engineering, and Operations teams to troubleshoot process issues and implement sustainable improvements. Quality Systems & Compliance Ensure compliance with applicable FDA regulations, ISO 13485 standards, and internal Quality Management System (QMS) requirements. Lead and support CAPA investigations, including root cause analysis, corrective action implementation, and effectiveness verification. Manage product complaint investigations, ensuring timely documentation, investigation, resolution, and appropriate escalation. Support nonconformance investigations, deviation management, and quality-related process changes. Participate in internal and external audits and support regulatory inspection readiness. Maintain accurate and compliant quality documentation. Continuous Improvement & Cross-Functional Support Identify opportunities to improve manufacturing processes, reduce defects, and enhance product quality. Collaborate with cross-functional teams to resolve complex manufacturing and quality challenges. Provide technical quality engineering guidance during process development, validation, and manufacturing changes. Support risk assessments and change control activities to ensure continued product safety and regulatory compliance. Drive continuous improvement initiatives focused on process capability, manufacturing consistency, and defect prevention. Required Qualifications Bachelor's degree in Engineering or a related technical discipline. 12+ years of relevant Quality Engineering experience , including substantial experience within the medical device industry. Strong experience working in regulated medical device manufacturing environments. Demonstrated expertise in process validation, including writing and executing

IQ/OQ/PQ

protocols . Strong background in process engineering, manufacturing process changes, and change control. Hands-on experience managing CAPA investigations and implementing effective corrective and preventive actions. Experience with product complaint investigations and complaint management processes. Working knowledge of FDA medical device quality requirements and

ISO 13485.

Strong root cause analysis, problem-solving, and technical documentation skills. Ability to independently lead quality engineering projects and collaborate effectively across multiple departments. Preferred Qualifications Experience supporting complex medical device manufacturing processes and equipment validations. Knowledge of risk management principles, including

ISO 14971.

Experience with statistical process control, process capability studies, and continuous improvement methodologies. Experience with manufacturing process transfers, equipment qualification, and quality improvement initiatives. Previous experience in a senior or lead Quality Engineering capacity. Ideal Candidate Profile The successful candidate will be a seasoned, hands-on Quality Engineer who brings extensive medical device manufacturing experience and can make an immediate impact. We are particularly interested in candidates who have personally developed and executed validation protocols, led CAPA and complaint investigations, supported manufacturing process changes, and demonstrated success resolving complex quality and process engineering challenges. Local candidates are preferred; relocation assistance may be considered for exceptionally qualified candidates. Additional Information This opportunity is best suited for an experienced quality engineering professional seeking a senior-level technical position within a regulated medical device manufacturing environment. 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. #

GRPA Pay:

$80.00 - $90.00 per hour

Benefits:

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

Work Location:

In person