Job Description:
Oversees the management of quality assurance programs and directs activities pertaining to product development, quality engineering, and continuous improvement of quality processes for medical businesses.
Provides direction on supplier capability and quality control plan assessments. Drives resolution of supplier quality issues. Ensures corrective action/preventative action items are addressed in a timely manner and issues are resolved.
Builds strong productive relationships with suppliers, sourcing, operations and research and development teams to maintain a reliable supplier chain of products, components and services that consistently meet or exceed requirements.
Drives effective and efficient quality techniques such as risk analysis, test method development, design of experiments, statistical analysis, measurement system analysis and development of sampling plans throughout the product life cycle.
Provides leadership in compliance and efficient supplier quality management processes. Ensures processes are followed and maintain appropriately.
Formulates short-term to mid-term planning, policies, programs and objectives relating to the medical quality assurance division and ensures organizational goals/objectives are met efficiently and economically.
Directs and oversees the strategic integration and execution of company plan within the medical quality division. Responsible for all medical quality divisional activities pertaining to supplier quality management, manufacturing quality assurance, and quality process development/improvement.
Establishes goals and objectives for division aligned with strategic plans set by top executives. Directs activities of subordinate managers in the accomplishment of quality plan goals and objectives.
Counsels and advises subordinates concerning performance. Coordinates training of members to improve performance and ensure compliance to regulatory standards.
Initiates and/or recommends/approves personnel actions such as hires, promotions, transfers, discharges and corrective or disciplinary measures.
Supports validation and verification strategy for new and existing products/processes.
Oversees product complaint investigations and ensures correction measures are adequate, validated and implemented.
Develops, negotiates and implements quality agreements with other organizations.
Manages facility audits by outside agencies to demonstrate compliance. Ensures any issues are corrected and countermeasures implemented in order to remain compliant. Acts as key point of contact to regulatory agencies.
Prepares reports on performance and activates of division and presents to executives.
Develops and maintains departmental budget. Ensures department operates within budgeted guidelines.
May be assigned additional duties and/or special projects.
Qualifications:
Requires a Bachelor’s Degree in Life Sciences, Engineering, Physical Science or related field. Master’s Degree preferred, with 8-12 years’ experience in quality assurance in the medical device industry and at least 5 years supervisory/management experience.
Extensive knowledge of the Federal Drug Administration regulations, ISO 13485 and Canadian medical device regulation.
Able to make timely critical decisions regarding product quality and or quality system compliance.
Ability to effectively direct teams.
Ability to use/implement statistical process control and DOE techniques.
May have to work overtime and may be assigned to other shifts based on company needs.
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