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Manager Quality Assurance
Il y a 5 mois
**Manager Quality Assurance**
We are looking for an engaged leader to join Stryker Montbonnot as Manager Quality Assurance. As leader of a dedicated Quality Operations team and associated suppliers for our Trauma & Extremities site in Montbonnot, you provide direction in Quality Assurance within Operations and other Business Functions, with a focus on preventative measures and continuous improvement of products and processes. You have 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.
**What you will do**:
Working within the Quality Operations structure, in a leadership capacity, the Manager Quality Assurance 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 organization’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 programs such as Corporate, Notified Body, MDSAP & 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.
- Timely resolution of supplier-initiated change requests and supplier deviations including product related NCs detected during incoming inspection and/or supplier audits.
- 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.
- The Manager Quality Assurance is the deputy of the local Senior Manager/Director, Quality Assurance in all business and compliance aspects.
- Supports the weekly, monthly quarterly and annual quality reporting including the yearly Quality Review.
**What you need**:
- Education: degree in Engineering, Science discipline or equivalent is mandatory. Business Management or MBA is an advantage.
- Minimum of 8 years of experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or regulated manufacturing environment.
- Experience of successfully creating and managing a talented, engaged and performing team is advantageous.
- Ability to implement organization and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level).
- 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 environment, interacting effectively at all levels, and across all functions with ability to develop organizational 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 s
