Director, Quality Assurance

Kalamazoo MI Stryker

Work Flexibility: Onsite

Leads the Quality Assurance team for a site(s) with focus on Quality Assurance activities with responsibility on delivering key quality and compliance results through subordinate leaders for one or more sites.

Essential Duties & Responsibilities

  • Responsible for delivering key Quality, compliance and business results through managing subordinate Site Quality Assurance leaders.
  • Ensures alignment of Quality programs within the COE (centre of excellence) strategies for the site(s).
  • Ensures appropriate quality systems and organizational structures are in place to meet quality expectations and business needs.
  • Provide SGS quality leadership with periodical quality performance assessment for each manufacturing site.
  • Ensure that there is effective and timely communication of product quality issues to ensure the mitigation of risk.
  • Ensure that the site's conformance and commitment to quality meets or exceeds customer requirements and the relevant regulatory standards.
  • Sponsors an environment of compliance within Stryker by working with business partners to define and maintain expected quality standards.
  • Champions a positive employee environment by promoting open communication, engagement and development of team members. Promotes a culture of trust, flexibility, teamwork and inclusiveness.
  • Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed.
  • Ensures the site(s) maintain continued certification to all regulatory bodies. Sponsors and ensure engagement in all internal and external audit programs such as Corporate, notified body & FDA inspections.
  • Foster collaboration, develop partnerships, and participate in multi-disciplinary Quality teams across the region and with all internal and external stakeholders to shares best practices with other regions/sites.
  • Leverage shared services and drive common processes to improve quality and reduce cost.
  • Ensure deployment and exchange of regional talent and leverage geographic synergies.
  • Ensures effective management and control of product/process deviations and implementation of effective corrective and preventive action.

Education and Special Training Required

  • Degree in Engineering Degree with Science discipline or equivalent.
  • Minimum of 10 years' experience in a technical role, 7 years of which in a Quality Management position in the Medical, Pharmaceutical, Bio-Medical/Pharma or Automotive manufacturing environment

Preferred Qualifications:

  • Minimum of 10 years' experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team
  • Leadership ability to develop and implement organization and functional strategy. Initiates, sponsors and implements change and a demonstrated track record in QA Improvement
  • Ability to develop organizational relationship and build trust
  • Works with a sense of urgency and attention to detail at all times
  • Solves problems by gathering data and using logic to arrive at decisions or solutions that achieve the desired outcome. Excellent data handling capability and analytical skills required
  • Makes timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions
  • Works cooperatively with others to produce innovative solutions. Demonstrates Initiative
  • Mentoring, coaching and performance management
  • Experience of managing inspections/audits by the FDA and other regulatory bodies
  • Knowledge of 21 CFR Part 820 and ISO 13485
  • Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
  • Uses interpersonal, relationship-based skills to convince and influence others.
  • Resolves conflicts and disputes by addressing multiple viewpoints to develop a mutually satisfying outcome.
  • Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization.
  • Demonstrates success working with others, learning from others, and building consensus to achieve established goals.
  • Effectively interacts and communicates with diverse internal and external audience.

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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