The Quality Systems Manager will be responsible for all aspects of the Bioscience Quality Management System (QMS) designed to be aligned with FDA 21 CFR 820 and ISO 13485:2016 in support of product and reagent development and production. This individual will provide support for all aspects of the QMS, including but not limited to, full product life cycle, and oversee testing of processes and products for Grand Rapids Site. As deemed necessary, the Quality Systems Manager may be required to perform other duties not listed on the essential responsibilities.

Reports to: Director of Quality Assurance & Regulatory Affairs

RESPONSIBILITIES

• Ensures that project/department milestones/goals are met and adhering to site goals. Has full authority for personnel actions. Extensive knowledge of the function and department processes.

• Authorize and serve as Management Representative as defined by the FDA QSR and ISO 13485 to represent company during compliance audits.

• Ensure that processes needed for the quality management system are established, implemented, and maintained in order to uphold our ISO certification status.

• Lead in the establishing and maintenance of the quality systems, policies, procedures and controls

• Act as the primary Quality contact/administrator of the corporate electronic Quality Management System (eQMS)

• Liaise with customers, external parties, and internal departments on matters of the QMS

• Develop and monitor quality system processes, including CAPA, change control, design control, complaint investigations, supplier oversight, internal audit, nonconforming materials

• Provide complaint handling support, including trending, reporting, investigation, closure

• Provide quality input for product development, manufacturing, and external suppliers as they relate to the companies’ quality solutions and products

• Participate in internal and external audits, including customer audits

• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers. Coordinate all necessary follow up actions

• Manage training for eQMS and provide QMS training for new hires

• Provide data, trending and detailed analyses to support daily quality management

• Serve as project management support- Communicates with project managers on quality system requirements.

• Assist in promoting and advancing a Quality Culture within the organization

• Participate in cross site quality forums and activities.

QUALIFICATIONS

Technical

• Bachelor’s degree (required) in chemistry, biochemistry, biophysics, bioengineering or related field. Master’s degree preferred.

• ASQ CQA, CQT, CQE, or CMQ/OE certification a plus

• In-depth knowledge of FDA 820 ISO 13485 ISO 14971. Hands on experience required.

• 5+ years of experience in the medical device industry involving product development and manufacturing

• 7+ years of multiple simultaneous projects QA or client-facing QA consultancy

• 5-7 years of quality assurance and quality managerial experience

• Proficiency with precision measuring tools and calibration

• Knowledge of 21 CFR 820, ISO 13485:2016, and ISO 14971 processes

• In-depth knowledge of FDA 820 ISO 13485 ISO 14971. Hands on experience required.

• Experience or knowledge with process or software validations a plus

• Familiarity with eQMS, IVDR, EU IVDR, ASR, internal or customer audit experience desired

• Thorough understanding of design and development procedures and practices that align with ISO and cGMP’s (FDA).

• Excellent written/verbal communication and presentation

• Strong analytical and problem-solving skills with attention to details.

Other 

• Strong Quality Systems and Quality Assurance Experience.

• Ability to work proactively and with a team.

• Excellent organizational, interpersonal, and communication skills.

• Proficient in MS Office (Excel, Word, PowerPoint) and Outlook, Excellent Data entry skills with ability to process large amounts of information both efficiently and accurately. Experience working with ERP system.

• Multi-tasker/Handle stress well under pressure.

• Positive attitude and enjoy fast past environments.

• Self-confident with ability to assess situations and make sound decisions and/or solve problems autonomously

• Strong sense of urgency

• Commitment to continuous improvement

• Customer-focus balanced with business sense

• Ability to set priorities

• Active Listener