Provides leadership and direction at the facility level, regionally and throughout the AST (Applied Sterilization Technologies) organization in ensuring that Quality Systems/Regulatory Compliance (QS/RC) goals, objectives and activities align with Customer and regulatory goals, as well as operational goals.
- Performs all functions and responsibilities of a facility Quality Systems Manager.
- Maintains professional skills, knowledge and abilities by attending educational workshops, reviewing professional publications and participating in professional societies.
- Ensures that FDA rules and regulations are adhered to. Maintains a working knowledge of regulations and establishes a monitoring program that responds to audit activity in a constructive manner.
- Provides leadership and direction in ensuring that Quality System activities within the region are consistent with QS/RC goals, objectives, strategies and tactics. This is accomplished through the ongoing and systematic identification of opportunities for improvement and ensuring that corrective and preventive actions required as a result of internal, Customer and regulatory audits, non-conformance, system deviations and Customer complaints are responded to in a manner which meets requirements and business objectives.
- Manages, monitors and mentors the regions Quality System technicians and/or analyst through ongoing performance feedback and formal reviews, as well as development initiatives which target individual strengths and weaknesses while delivering business results.
- Assists the Director of QS/RC in developing an AST strategy that integrates the QS/RC function, its processes, as well as the managers as partners with operations.
- Assists with the establishment and adheres to a QS/RC budget as well as monitoring that budget through the establishment of controls and review of expenditures.
- Assists the Director of QS/RC in the preparation of periodic management reviews and ensures appropriate follow up on all recommended corrective action(s).
- Informs the Director of QS/RC of scheduled and unannounced QS audits by Customers, standards bodies and regulatory agencies through updates regarding potential regulatory or standards body identified non-compliance or risks, discussion and review of audit responses and resulting follow through.
- Supports a safe, clean and secure working environment by supporting procedures, rules and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions.
- Promotes and protects the company reputation by participating and representing the company in local community activities.
- Communicates in an effective manner by utilizing accepted business practices in a courteous and professional manner providing timely and accurate responses and service oriented offers of assistance.
- Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
- Exhibits a commitment to the AST shared values of Customer Satisfaction and Continuous Improvement through ensuring defect-free workmanship, assisting others to meet the Customer?s needs, searching for efficient and effective ways to reduce waste, being active and accountable for Customer satisfaction, and satisfying the Customer?s needs with a sense of urgency.
- Contributes in a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the GMP, Lean principles and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
Required Experience and Education
- A minimum of five to seven (5-7) years of experience managing quality systems in medical device manufacturing or in sterilization operations required; Quality System FDA regulations and validation is preferred.
- Demonstrated experience managing associates to include technicians and/or analysts.
- ISO9000 and ISO13485 standard and AAMI industrial sterilization methods experiencepreferred and experience with statistical technique such as SPC and experimental design experiencepreferred.
- Ability to effectively read, write and verbally communicate.
- Ability to work independently under general guidelines and supervision.
- Computer skills and work processing, spreadsheet ad software capabilities.
- Effective interpersonal skills as demonstrated through prior management experience
- Above average organizing, analyzing and Level 4 math skills (advanced algebra and/or calculus and/or statistics) to determine organizational Customer and regulatory problems and formulate corrective action plans; attention to detail.
- Ability to adapt to changing duties and responsibilities.
- Ability to influence people in the opinions, attitude or judgments, to generalize, evaluates and decides, to adapt to situations under stress.
- Normal hearing range sufficient to hear alarms, bells, horns, etc.