Medical Device, Senior Quality Engineer

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

Why JOIN Us?

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.

Want More INFO?

The Medical Device, Senior Quality Engineer will lead and implement quality improvement, remediation initiatives, and facilitate the change management process within the PENTAX Medical facility. This role is vital to the functionality of cross departments to ensure timely CAPA evaluations/investigations, determining root causes and effectively implement the remediations.

Responsibilities of Medical Device, 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 CAPA and Change Management processes
• Develop strong working relationships with domestic and global partners to ensure consistent, effective CAPA and Change Management processes
• Develop CAPA and Change Management training programs and conduct training for new/existing employees
• Support Management Review
• Support Document Control and Training processes
• Participate on the Internal Audit team
• Interact with regulatory bodies during inspections/audits
• Manage site-wide initiatives/projects as needed

• A Bachelor's degree in Engineering, Life Sciences or related field (Masters preferred)
• Minimum 5 years' Quality System experience in an FDA and/or ISO regulated environment
• Thorough understanding of CAPA processes, Product and Process Change Management, and Quality Systems
• Six sigma certified
• Strong ability to manage critical projects
• Excellent problem solving, technical writing, and communication skills
• Self-motivated and detail-oriented
• ASQ Certified Quality Engineer (CQE) and/or ASQ Certified Quality Auditor, and/or ISO13485 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.