Manager, Quality Systems in Allendale, NJ at Stryker Corporation

Date Posted: 9/18/2019

Job Snapshot

Job Description

As a Manager, Quality Systems, you'll have an opportunity to

  • Provide strategic and tactical QMS leadership within the QARA environment

  • Promote and enhance Stryker Spine’s quality policy and quality system

  • Provide QMS support to all processes in Spine Division

  • Plan, organize and implement strategies and activities required to ensure overall compliance with applicable global regulatory and statutory requirements regarding document control, change control, control of documents of external origin, training, EH&S, master data and other elements of the QMS as required

  • Manage, implement and maintain the quality system processes in compliance with the applicable standards and regulations

  • Manage day-to-day quality systems processes to ensure issues are appropriately evaluated

  • Establish annual budgets and quarterly forecasts.

  • Make necessary changes with appropriate management involvement

  • Communicate and collaborate with Quality Assurance, R&D, Global Supply, Finance, Sales, and Marketing departments to ensure corporate and divisional goals and strategies are met

  • Serve as Subject Matter Expert for quality system processes

  • Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations

  • Establish standard process to ensure appropriate resolution and management of the responsible task owner

  • Chair meetings required to drive closure of quality system issues

  • Manage and provide updates for quality system metrics

  • Implement appropriate enhancements

  • Represent quality system processes during internal and external audits

  • Correspond with agencies regarding compliance issues, as needed

  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets

  • Recruit, select, and on-board top talent to effectively support and continuously improve the Quality Management system

  • Develop talent within team to increase performance. Actively address performance issues on team

  • Maintain a high level of team engagement

What you need

  • Bachelor's degree in a science, engineering or related

  • 9+ years experience in developing and implementing quality management systems

  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements

  • Demonstrate technical knowledge of medical device product lines

You may also have

  • Advanced degree

  • Demonstrated ability to lead a variety of work groups, including multi-national teams, to assure conformance to regulatory requirements, internal processes and procedures.

  • Demonstrated ability to lead a team of individual contributors along with recruiting and people development skills

  • Demonstrated excellent communication skills and ability to work with employees at all levels of the organization

  • Demonstrated written, verbal, listening, communication, and team-building skills

  • Demonstrated ability to effectively prioritize and manage multiple project workloads

  • Demonstrated process improvement and management skills

  • Strong ability to influence across the organization

Work From Home: No

Travel Percentage: Up to 50%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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