American Contract Systems (ACS) is a fast-growing contract packaging and sterilization company located in Bloomington, MN with operations in numerous locations within the United States.
ACS has an immediate opening for a Quality Assurance Director. As a key member of our management team, this person, working closely with operations management at the corporate and plant levels, will be primarily responsible for establishment of the design, implementation and maintenance of policies and procedures that comprise the ACS Quality System. The Quality Assurance Director reports directly to the Chief Operations Officer with a strong dotted line relationship to the company’s President.
Primary Quality Management Representative for the Company.
Manage the customer complaint / MDR system.
Ensure that all requirements in the FDA Quality System Regulation and related regulations, standards and guidelines, including state and local government health department regulations are captured in applicable ACS procedures or specifications.
In cooperation with the VP of Operations, ensure that a system is established so that all facilities implement and follow quality control guidelines and policies, ACS policies, procedures and specifications.
Review and approve all new and/or revised procedures and specifications prior to their issuance.
Establish and maintain documentation for product handling and sterilization procedures in cooperation with the VP of Sterilization.
Train corporate and plant management in basic statistical quality control tools and techniques.
Ensure that plant management personnel are sufficiently trained to interact with FDA and other regulatory authorities during inspections.
Manage FDA inspections and act as the primary interface between the Company and regulatory agencies.
Revise and maintain the Quality System training process.
Stay up-to-date on FDA enforcement trends, pending or proposed FDA regulation changes and industry developments that may affect the ACS business.
Manage the internal audit to determine the compliance posture of the Company and keep senior management aware of findings and resolution progress.
Conduct audits of ACS's purchased materials suppliers on a risk-based frequency.
Chair the CAPA and Material Review Boards.
Maintain working knowledge of TQM (Total Quality Management) practices and techniques and how it applies to our industry and products.
Bachelor's degree in a related field required
Strong knowledge and experience with FDA regulations and participation in FDA inspections
Thorough knowledge medical device sterilization
Ability to travel as required for business
Extensive Quality Management experience, in the medical device manufacturing industry
Working knowledge of international regulatory regulations and standards helpful
Strong working knowledge of Microsoft programs Experience with electronic publishing tools and electronic document management preferred
About American Contract Systems
American Contract Systems was founded in 2000. ACS has headquarters in Bloomington, Minnesota and currently employs staff in ten states, where we package and sterilize surgical trays for hospitals and clinics throughout the country.
ACS is managed by a small competent group whose aggregate experience in the custom pack industry exceeds 350 years. All are fully committed to the direction and approach we have thoughtfully chosen, and pragmatic in its execution. While we appreciate being regarded as creative, innovative, and imaginative, we are diligent to remain realistic.