Quality Manager (ISO 13485)

Description

Seeking an experienced Quality Manager to join our team at Polyzen in Apex, NC!

The Ideal candidate will possess 7 years of demonstrably successful experience in quality assurance or regulatory, preferably within an ISO 13485-certified medical device manufacturing environment. This role ensures product quality and regulatory compliance, maintaining Quality Management System (QMS) requirements and quality assurance processes such as Document Control, CAPA, NCRs, and internal/external audits, to ensure product safety, reliability, and compliance with applicable regulations. In addition to overseeing these critical functions, they will also manage the Quality staff. This is an on-site position.    

What you will do:

• Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Maintain product quality by enforcing quality policies, procedures, and applicable statutory and regulatory requirements.
• Act as Quality liaison between the organization and customers.
• Responsible for maintaining ISO 13485:2016 certification and compliance to 21 CFR Parts 820, 210 and 211.
• Interpret and communicate international regulatory product requirements and as applicable submit and maintain product registrations.
• Assist with the Quality and Regulatory Planning in conjunction with company’s strategic objectives.
• Compile and assist with data analysis and overall trending, including Key Performance Metrics for review on monthly, annual and during Management Review meetings.
• Identify and communicate changes to standards and regulatory requirements.
• Ensure the conformity of products is appropriately checked in accordance with quality system requirements prior to the release and, when necessary, certifies finished goods.
• Review and approve validation documentation, product specifications, standard operating procedures and any revisions to these documents ensuring they are conducted in accordance with the requirements of the FDA and ISO.
• Review and authorize deviations and, when necessary, facilitate appropriate review boards for deviations and specification changes.
• Collaborate with other members of management to develop new product and engineering designs.
• Review and support customer advisories, post-market surveillance and responsibility for disposition of authorization returns as applicable.
• Support training on the Quality Management System.
• Assist manufacturing to improve efficiency and decrease waste; monitor nonconforming product disposition and control, advise senior management, as necessary.
• Support the evaluation of raw material out of specifications and determining disposition of any rejects, quarantines, etc.
• Ensure label claims and content of promotional materials meets statutory and regulatory requirements.

Qualifications

Who you are:

• Bachelor’s degree or equivalent experience.
• Certified ISO 13485:2016 Auditor
• Minimum of 4 years managing direct reports.
• Minimum of 7 years in a regulated environment (e.g., ISO 13485:2016, 21 CFR Parts 810, 811 and 820) in one of the following functions: Quality Control/Assurance or Regulatory, preferably in an environment with onsite manufacturing.
• Extensive knowledge of regulatory requirements, including, but not limited to: ISO 13485:2016, FDA Quality System Requirements 21 CFR Parts 210, 211 and 820.
• Direct experience with customer, supplier audits and inspections by regulatory authorities.
• Knowledge of FDA Medical Device Submission Process (510K, Letter to File, MDR, etc.) and experience playing an active role in submissions that led to approval for commercialization.
• Familiarity with trends in regulatory affairs.
• Demonstrated successful track record in development and implementation of compliance strategies.
• Must be able to work extended hours when required.

Travel requirements:

• Between company facilities, as needed.
• May have to travel to Supplier for auditing purposes.