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. Want More INFO? The Quality Inspector role is responsible for assisting the Quality Assurance organization in implementing and maintaining quality management tools and controls that ensure product, processes and services are compliant with FDA and ISO quality system requirements. This role utilizes engineering skills and tools to investigate problems, employ solutions, implement improvements and drive quality controls in order to improve overall quality of product and processes.

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

Qualifications:

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 Must be able to work on-site in Montvale, NJ Monday - Friday. It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. 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