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Position:
Senior Quality Engineer
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Job Id:
20260413SQE
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# of Openings:
1
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Ourmission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.
Position Opening: Senior Quality Engineer
We are an established medical device leader that is preparing for high growth. This means that PENTAX is looking to invest in its team and provide a collaborative and encouraging work environment.
PENTAX Medical is proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy.
The Sr. Quality Engineer, QMS will lead and implement quality improvement, remediation initiatives, and facilitate the change management process within the PENTAX Medical Montvale, NJ facility. Partner with cross functional departments related to quality initiative and to ensure timely CAPA evaluation/investigation, root cause(s) determination, action plan development, and effective implementation.
The Sr. Quality Engineer QMS will also prepare periodic metrics to ensure the effectiveness of the Quality System, CAPA and Change Management processes. Lastly, the incumbent is responsible for ensuring the CAPA and Change Management processes meet all applicable global regulatory standards and that comprehensive records of all required activities are maintained.
Responsibilities of Senior Quality Engineer
- Utilizing cross functional teams, facilitate the investigation of CAPA and identify action plans
- Maintaining thorough, well documented records of all CAPA activities
- Monitoring and facilitating the timely completion of all CAPA activities including, but not limited to, evaluation, investigation, action completion, and verification of effectiveness
- Facilitate the effective implementation of Product and Process changes by leading the site Change Management process
- Manage the CAPA and Change Management review board agenda(s), facilitate periodic meetings, and generate minutes
- Monitor and facilitate the timely completion and closure of Product and Process changes in the Change Management program.
- Prepare periodic metrics to ensure the effectiveness of the Quality System, CAPA and Change Management processes
- Develop strong working relationships with domestic and global partners to ensure consistent, effective Quality System, CAPA and Change Management processes
- Develop CAPA and Change Management training programs and conduct training for new/existing employees
- Support & Lead Management Review
- Support & Lead Document Control and Training processes
- Participate in the Internal & External Audit team
- Interact with regulatory bodies during inspections/audits
- Manage site-wide initiatives/projects as needed
Requirements of
Senior Quality Engineer
- Bachelor's degree in Engineering, Life Sciences or a related field (Masters preferred)
- Minimum of 5 years' Quality System experience in an FDA, MDR, and/or ISO regulated environment
- Thorough understanding of CAPA processes, Product and Process Change Management, and Quality Systems in general
- Six sigma certified or demonstrated proficiency in quality investigations
- Strong ability to manage critical projects as part of an interdisciplinary team
- Excellent problem solving, technical writing, and communication skills
- Must be self-motivated and detailed oriented
- ASQ Certified Quality Engineer (CQE) certification and/or ASQ Certified Quality Auditor and/or ISO 13485 or MDSAP lead auditor a plus
It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.
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Apply for this Position
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PENTAX Medical
paid time off
Apr 13, 2026