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.
More Information
Application Details
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Organization Details
Stryker
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