Senior Manager, Quality Assurance in Kalamazoo, MI at Stryker Corporation

Date Posted: 10/28/2020

Job Snapshot

Job Description

Who we want

Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Insightful advisors. Managers who lead strategy development and provide guidance to teams.

Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

What you will do

Direct and monitor quality programs and systems for the assigned Operations site(s) to ensure Stryker products consistently meet or exceed expectations, and that all quality related regulatory requirements are met. Partner with leadership from Global Quality and Operations and Stryker Divisions to develop strategies for improving quality, cost, and service for new and existing products and processes.

  • Ensure products and processes consistently conform to Stryker, FDA, ISO and other quality related regulatory requirements, including systems for Purchasing Controls, Identification and Traceability, Production and Process Controls and Changes, Nonconforming product and CAPA, Acceptance Activities (Inspection and Test Service).
  • Ensure harmonization and standardization of quality systems, metrics and processes across the sites as feasible.
  • Effective management and/or support to audits from quality related regulatory agencies and notified bodies at assigned Operations site(s), in partnership with Division RAQA heads and Operations leadership.
  • Product identification and traceability is maintained through various stages of the manufacturing and distribution process.
  • Ensure processes are in place to address product handling and storage, reprocessing, rework, and product release consistently across manufacturing sites.
  • Processes are in place to provide for appropriate and consistent product and/or related investigations and CAPA at assigned operations site(s).
  • Adequate inspection and tests are being carried out and containment activities immediately as required.
  • Effective and timely communication with Division RAQA leaders of any potential field actions and product holds being investigated,
  • Successful execution of quality-related supplier management activities, including audit, CAPA and change management.
  • Successful execution of quality engineering-related activities, including problem solving, product and process quality improvement.
  • Successful execution of quality control-related functions, including acceptance activities, product testing, product disposition.
  • Development and monitoring of budgets for the assigned Quality function, including ensuring appropriate resources to meet/exceed plant quality goals and Global Quality and Operation and Divisions’ objectives.
  • Hire, coach, develop, and mentor Quality staff to ensure their ongoing career development and personal effectiveness.
  • Perform Staffing reviews of subordinates and oversees the staffing of the Quality teams at the Campus.
  • Allocate/re-allocate internal and external resources as needed to ensure the appropriate Quality organizational structures are in place to operate a compliant operations business unit.
  • Initiate training programs to advance understanding of regulatory requirements and quality concepts.
  • A culture of partnership, transparency, service and collaboration exists between Global Quality and Operations, Divisions, and Operations.
  • Promoting and strengthening the Culture of Quality First throughout the organization.
  • New products are successfully transferred to manufacturing sites and suppliers, resulting in a timely launch of high-quality products.
  • Effective monitoring of key quality data for assigned plants and suppliers, including product quality trends and reporting.
  • Leadership in planning and execution of operations internal Quality compliance audits and CAPAs.
  • Support of Global Quality and Operations Due Diligence, Acquisition and integration activities as required.
  • Strategic plans and quality objectives are developed that support Global Quality and Operations. Evaluation of site performance against those goals and priorities. Executive leadership of management review responsibilities.
  • Collaborate and support of companywide quality planning continuous improvement projects.

What you will need:

Basic Qualifications:

  • Bachelor’s Degree is required.
  • Minimum of 10 years relevant working experience in a GMP manufacturing environment in Medical Device, Pharma, Automotive or Aerospace industry.

Preferred Qualifications:

  • Prior people management experience is strongly preferred.
  • BS in a science, engineering or related field preferred.
  • Master's Degree or equivalent preferred.

Work From Home: Occasional

Travel Percentage: 20%

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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