Senior Manager, Quality Systems (Direct Hire)
South Plainfield, NJ
Job Requisition: 6571
Description for Sr. Manager, Quality Systems:
The Senior Manager, Quality Systems provides leadership and direction at the facility level, regionally and throughout the 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. This position will be based in South Plainfield, NJ but will also support another facility in Northborough, MA. Ability to travel is required.
Responsibilities for Sr. Manager, Quality Systems:
- Performs all functions and responsibilities of a facility Quality Systems/Regulatory Compliance (QS/RC) 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 QS/RC 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 QS/RC Managers 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 a company 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 company 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 company Code of Business Conduct, the GMP, Lean principle and other directives; supports the directives and decisions of higher level management and performs other duties as assigned.
Requirements for Sr. Manager, Quality Systems:
- Bachelor’s Degree in Engineering or Science. Preference is given for ASQ certification
- Minimum of five to seven (5-7) years of experience in medical device manufacturing or in sterilization operations, and Quality System FDA regulations and validation is preferred.
- ISO 9001 and ISO 13485 standard and AAMI industrial sterilization methods experience and experience with statistical technique such as SPC and experimental design experience is highly preferred.
- Experience leading internal and customer audits.
- Ability to routinely be customer facing.
- Previous leadership experience with direct reports.
- Ability to effectively read, write and verbally communicate.
- Ability to travel regionally.
- 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.
Desired for Sr. Manager, Quality Systems:
- Advanced degrees or Quality Certifications: CQE, CQA, CQ Mgr., Six Sigma or Lean.
- ISO 13485 and FDA GMPs.
- Experience with statistical analysis software, Statistical Process Control (SPC), and trending metrics analysis
*Legal authorization to work in the U.S. is required. Will not sponsor individuals for employment visas, now or in the future, for this job opening