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Northern Ireland / Tuaisceart Éireann, United Kingdom
Onsite
Senior Manager, Quality Assurance - **Onsite - Model Farm Road **
As a global partner & leader of the Quality Operations team for one or more sites, has responsibility for delivering the strategic, compliance and business objectives of the function, with primary responsibility in developing & leading quality within operations and other business functions. Will focus on preventative measures and continuous improvement of products and processes and drive engagement of the quality team, while ensuring compliance to Stryker Corporate and SGS requirements, Quality System Regulations and standards.
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 multiple high performing quality team across disciplines, that provides 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.
Sponsors an environment of compliance within Stryker by working with business partners 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.
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 ensures engagement 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.
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.
With global alignment, develops 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.
Foster strong collaboration on a global scale, 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.
Ensure the responsibilities related to the PRRC, Person Responsible for Regulatory Compliance, per EU Medical Device Regulation are in place at the manufacturing site.
Education/Requirements
Bachelor’s Degree in Engineering, Science discipline or equivalent. Business Management or MBA is an advantage.
Minimum of 10+ years experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
Minimum of 6+ years experience and a proven track record of successfully creating and managing a highly talented, engaged and performing team.
Experience in multiple areas / sites/ positions in the quality organisation is advantageous.
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.
Demonstrated leadership ability to develop and implement organisation and functional strategy. Initiates, sponsors and implements change with a demonstrated track record.
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.
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Travel Percentage: 20%