Manager, Quality Assurance

Work Flexibility: Onsite

Job Title

 Manager, Quality Assurance

Reports To

Sr Manager/Director/Sr Director/Vice President, Quality Assurance (or people leader grade above) Position Summary

As leader of a dedicated Quality Operations team for a site (s), provide direction in quality assurance within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Has responsibility for delivering the compliance and business objectives of the function, with primary responsibility to drive engagement and lead the quality team, while ensuring compliance to Stryker Corporate and SGS requirements, Quality System Regulations and standards.

Key Areas of Responsibility

Working within the Quality Operations structure, in a leadership capacity, has responsibility for quality related activities which includes, but not limited to the following:

• Leadership of a high performing quality team, that provides direct support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality.
• Ensure that the organisation’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory standards.
• Drive an environment of compliance within Stryker by working with all function managers and their support staff to define expected quality standards and the roles/responsibilities in the maintenance of these 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, ensuring all relevant Quality functions (e.g. Shared Services Quality, Supplier Quality) are included in decision making processes as part of continuous improvement, problem solving and projects.
• Selects competent talent and supports the development of their future potential. Ensures effective training and performance management of the teams.
• Ensures the site(s) maintains continued certification to all regulatory bodies. Plays a lead role in all internal and external audit programmes such as Corporate, notified body & FDA audits.

• Ensures effective management and control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Manages product & patient risk.

• Develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management.
• Oversight and responsibility to ensure site maintains adherence to Quality KPIs performance indicators, and takes timely action to address adverse trends and deviations. Continuously monitors and partakes in global forums to assess opportunities for improvement.
• Foster strong collaboration on a global scale by participating in and leading cross functional and global process improvement initiatives.
• Has a strategic view in identifying global alignment and developing strategies for best in class practices and benchmark against industry leads and regulatory requirements for the Quality function.

Qualifications Knowledge Skills

• Bachelor’s Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage.
• Minimum of 8+ years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
• Minimum of 4 years experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team.
• Demonstrated leadership ability to develop and implement organisation and functional strategy.  Initiates, sponsors and implements change with a demonstrated track record in QA Improvement.

• Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies.

• Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.

• Must be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organisational relationship and build trust.

• Demonstrated ability to make timely and sound decisions, through effective approaches for choosing a course of action or developing appropriate solutions. Works with a sense of urgency at all times.

• The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines. Demonstrated Initiative.

Insert detailed job description here.

Travel Percentage: 10%