What are the responsibilities and job description for the Quality Control Inspector position at PENTAX Medical (USA)?
Our mission 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: Quality Control Inspector
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.
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Responsibilities of Quality Control Inspector:
- Assess existing corporate SOPs, local work instructions and quality record forms for purchasing, supplier assessment, incoming inspection, nonconformance and supplier audits and their related processes and edit as necessary.
- Execute specific incoming inspection procedures to ensure that adequate control is applied over suppliers and make recommendations for improvements, where appropriate.
- Execute specific in-process inspection procedures to ensure that adequate control is applied over manufacturing and servicing processes and make recommendations for improvements, where appropriate.
- Execute specific Final Product inspection and release procedures to ensure that adequate control is applied over the manufacturing and servicing of product and make recommendations for improvements, where appropriate.
- Prepare new supplier assessment forms, evaluate supplier’s ongoing capabilities and overall quality by utilizing metrics tools and scorecards, update the Approved Supplier List, as appropriate
- Assist with desk and/or on-site audits for critical suppliers
- Assist with process and software validation testing
- Apply and utilize statistical controls and tools to improve product quality
- Conduct investigation and resolution of non-conformances, supplier corrective actions (SCARs) and participate on the site’s Material Review Board
- Monitor/assess internal calibration and preventive maintenance systems
- Conduct cause investigations and implement corrective actions related to close CAPA
- Assist in conducting Internal Audits
- Other duties as assigned by management
- Engineering Technology educational background is preferred
- 3-5 years’ experience in the medical device, pharma or highly FDA regulated industry with some experience with supplier control and inspection and testing.
- Thorough understanding of FDA 21 CFR 820 and ISO 13485 regulations
- Excellent problem solving, technical writing, and communication skills
- Experience with SPC tools
- Must be self-motivated and detailed oriented
- Auditing experience 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.