JOB TITLE Manager, Quality Assurance REPORTS TO Manager/Senior Manager/Director, Quality Assurance POSITION SUMMARY As leader of a dedicated Quality Operations team for a site/area, 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 GQO requirements, Quality System Regulations and standards. KEY AREAS OF RESPONSIBILITY Will work within the Quality Operations structure, in a management capacity, has responsibility for quality related activities which includes, but not limited to the following: Leads Quality Engineering Team to provide support and technical guidance / direction to the operational and functional areas on site, fostering an environment of proactive and continuous improvement approach to Quality. Supports and aligns with the site commitment to ensure the organisationu2019s conformance to producing products meeting or exceeding customer requirements and the relevant regulatory standards. Fosters a positive employee relations environment by promoting open communication, engagement and development of team members. Promotes a culture of inclusiveness, trust, flexibility and teamwork. Create a highly talented team by sourcing, hiring, and placing individuals in positions that play to their strengths and future potential 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. Participates in ensuring 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 control of product/process deviations for all released product and for the implementation of effective corrective action when non-conformances arise. Assesses product & patient risk. Supports the 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. Assist in developing and supports local and global strategies for the Quality Operations function. Act as Management representative where delegation is obtained from relevant Stryker division quality leader. QUALIFICATIONS KNOWLEDGE SKILLS Candidate must have successfully completed a BS of Engineering, Science or equivalent related qualification and have at least 8 years relevant experience in a Regulated Industry. Minimum of 5 yearsu2019 people management experience and a proven track record of successfully creating and managing highly talented, engaged and performing teams preferred. Ability to implement organisation and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level) Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously. The candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines. Demonstrated Initiative. Self-starter with demonstrated efficient work methods, high analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment. 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. Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. 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 u2013 M/F/Veteran/Disability.