- The Quality Manager is the leader and technical head for the DAS quality activities for our company.
- This individual is responsible for supporting and driving quality initiatives throughout the site, including driving the goals and objectives in accordance with the DAS business unit and operational goals, supporting Regulatory compliance, and coordinating efforts to achieve compliance with new quality system standards by performing the following duties personally or through supervisors.
Duties and Responsibilities:
- Supports the development, implementation and maintenance of quality assurance systems and activities in compliance with ISO 9001, 2015 and certain elements of ISO 13485.
- Supports the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
- Supports the development and launch of new products including post launch complaints handling and continuous improvement activities.
- Supports development of budgets and monitors expenditures.
- Coordinates interdepartmental activities.
- Ensures finished products conform to government and company standards and regulations.
- Develops and evaluates personnel to ensure the efficient operation of the function.
- Monitors audits of production and Quality Control areas.
- Supervises technical documentation writers, including coordinating needs across product families.
- Oversees audits of raw material vendors and manufacturing documentation for updated filing.
- Lead investigations and resolve potential product quality issues for DAS to improve efficiency.
- Makes recommendations for corrective action necessary to ensure conformity with quality specifications.
- Supports generation and review of documents used in support of meeting all government and company standards and regulations.
- Works closely with the Directors of the R&D, Engineering and Operations functions to ensure that all systems and activities meet all required standards and are technically sound..
- Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Requires a BS degree in Engineering, or related program from a four-year college or university with 10+ years’ related experience and/or training; or equivalent combination of education and experience.
- Must have experience within a heavily regulated environment requiring compliance with ISO 9001, 13485; experience with FDA’s 21 CFR 820 highly preferred.
- Experience with Medical Device/Diagnostics instruments is preferred.
- Background in Six Sigma and Continuous Improvement programs preferred.
Knowledge, Skills & Abilities:
- Ability to read, analyze and interpret the most complex documents.
- Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management, public groups, and/or boards of directors.