Oversees all aspects of the Quality System and Regulatory Compliance program to ensure that industry best practices are implemented and followed with respect to quality assurance, quality control, process improvements, and quality/regulatory-related strategic planning. This is accomplished by leading the Quality Assurance staff in performing the duties below.
MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
- Establishes and maintains all corporate policies related to product and process quality; acts as the ISO/QS Management Representative for the organization.
- Plans, directs and implements strategic business plans involving product and process quality.
- Directs all aspects of a Quality System that is certified to ISO 9001 and/or ISO 13485 and that is compliant with the FDA’s current Good Manufacturing Practices (cGMPs):
- Implementing ISO/cGMP policies, operating procedures and work instructions
- Resolving internal product and process issues through established nonconformance and CAPA systems
- Addressing customer complaints in accordance with an effective complaint handling process
- Hosting customer audits and handling customer requests for quality-related information
- Interacting with the ISO Registrar in matters concerning the company’s Quality System certification status
- Directs all cleanroom compliance activities, the instrument calibration system, the corporate training program and the pest control program.
- Acts as the technical expert for all applicable regulations (FDA, ISO, AAMI, etc.) ensuring the proper processes, policies and procedures are in place to obtain customer part qualification approvals and to maintain regulatory compliance.
- Monitors external regulatory developments, identifies risks, and communicates potential issues to senior management.
- Owns the Supplier Quality Management Program. Works closely with subcontractors and suppliers to improve quality through pre-qualification reviews, on-site audits and performance evaluation and monitoring.
- Assures that engineering design and manufacturing activities are conducted in compliance with the Corporate Quality Plan and ensures that validation and testing processes are robust and implemented in a manner that cGMP, ISO and other regulatory requirements are met.
- Designs and generates reports, utilizing statistics and metrics, as appropriate, to evaluate trends and to aid management in the identification and resolution of quality issues and overall quality improvement efforts. Recommends KPI’s to measure compliance with quality standards and effectiveness of corrective actions across all functions.
QUALIFICATIONS (Education/Training, Experience and Certifications)
- Bachelor’s degree in science-related discipline or equivalent/applicable experience
- 8-10 years experience in some combination of Quality and Regulatory roles, some portion of which must include an environment related to medical devices and/or biopharmaceuticals
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- Proven ability to create the Quality and Regulatory strategies for an organization and the experience to lead others to achieve related goals
- Extensive knowledge of FDA regulations (including cGMPs – 21CFR Parts 820, 210, 211) and ISO 9001 / ISO 13485
- Extensive knowledge of Standards and FDA Guidance related to process validation, biocompatibility (USP / ISO) and sterility (ISO / AAMI)
- Ability to manage and report on high-visibility projects and drive them to conclusion.
- Strong communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees
- Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines
- Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small-to-mid size organizational environment