Quality Systems Manager
The Quality Systems (QS) Manager assures that products, processes, facilities and systems conform to ALPCO quality systems and government regulations. This position will help develop, implement and coordinate product quality assurance programs to prevent or eliminate defects in new or existing products at ALPCO. The QS Manager will also be involved in coordinating the review and maintenance of ALPCO’s Quality and Regulatory documents, and will support implementation and management of a Quality Management System in coordination with other departments. This position will have responsibility for assuring that ALPCO Quality Systems and Regulatory requirements are effectively identified and established, and ensure that all systems are compliant with current GMP and other regulatory requirements (FDA, ISO).
- Leads initiatives to establish and maintain quality assurance and regulatory programs across and within departments and functions to ensure that responsibilities and procedures for attaining QS objectives are met
- Leads QS management meetings to review and report on the ALPCO QS
- Manages internal quality audits, as required, to determine QS effectiveness and to assure compliance with the established regulatory requirements
- Participates in documenting the correction and prevention of customer complaint investigations and evaluates possible medical device reporting, as required; facilitates all external customer matters relating to ALPCO QS
- Responsible for review of product quality prior to release for shipment; approves or restricts shipment based upon product quality criterion or regulatory requirements; escalates product quality issues to the corrective or preventive action process for resolution, as necessary
- Coordinates and reviews employee training and understanding of all current QS and regulatory requirements
- Reviews and approves documents and procedures for accuracy as needed
- Leads and manages quality team members to ensure success
- Other responsibilities as assigned by management.
Skills & Qualifications
- Bachelors or advanced degree in the Sciences or a related discipline and 10+ years (BS), 8+ years (MS+), with QS experience in a GMP environment
- Strong management experience and delegation skills.
- Must have working knowledge and a sound understanding of FDA QSR’s (Title 21 Part 820) and ISO 13485
- Experience with FDA, Customer and ISO audits; preferably as the company designee
- Good project management skills with an ability to manage and organize work around multiple changing priorities
- Excellent oral and written communications, facilitation/presentation skills, including preparation of reports detailing procedures, observations, and conclusions
- Demonstrates personal awareness and desire for continual learning and personal development
- Ability to effectively present to all levels of an organization internally and externally
- Highly motivated and resourceful individual who constantly seeks new ways to improve how work is done
- Previous laboratory experience and understanding of work flow in an immunoassay based product environment is preferred