Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Position Summary
Lead a regional team of Supplier Quality Engineers to develop and implement improved supplier quality management processes driving a culture of continuous improvement to support Stryker’s mission & strategic goals. The supplier quality management processes will include supplier monitoring and targeted improvements. Improvements will be implemented using industry known improvement methodologies such as continuous improvement, lean/six sigma, audit and a variety of problem-solving tools to further develop quality capability within the Stryker Global Supply base.
Key objectives in this role are:
(1) Build with your team a stronger supply base with improved product quality to protect our customers and plants
(2) Significantly reduce the cost linked to quality issues (Defects, NC’s, CAPA’s, Escapes, PFA’s, Holds)
(3) Build with your team a culture of continuous improvement within Stryker’s supply base winning for our suppliers, our sites and our customers
What you will do:
- Manage a regional team of Supplier Quality Engineers to develop and implement quality improvement projects with suppliers.
- Apply leadership expectations (Setting Direction, Inspiring Others, Delivering Results, Building Organizational Capability and Developing Talent) to engage, develop and retain the team.
- Create a structure for your team, identify appropriate talent, create succession plans, develop job descriptions, objectives, Key Performance Indicators and performance goals.
- Perform effective evaluations assessing team members performance.
- Support the development of team members in association with their career path and create viable succession plans.
- Develop the team’s expertise and team dynamics through continuous coaching, promoting development programs and formal appraisals through the performance review process.
- Maintain an environment that promotes engagement and collaboration.
- Communicate and collaborate cross functionally to ensure corporate goals and strategies are met.
- Influence the organization across departments (i.e. Procurement, Quality, Operations, Regulatory) to drive the supplier quality strategy and make sound decisions based on supplier strategy and site / business direction.
- Manage and provide updates for supplier quality metrics.
- Drive continuous improvement activities to meet and exceed these metrics.
- Establish the use of standard processes and quality tools to ensure effective management and resolution of supplier issues.
- Drive strategic planning and management of supplier compliance activities with management responsibilities over multiple sites.
- Participate in supplier evaluations and monitoring as required, support the regional team to deliver the regional plan.
What you will need:
- Bachelor of Science in engineering or engineering related discipline preferred.
- Masters degree in engineering or engineering related discipline preferred.
- Minimum of 3 years relevant experience in Medical Device
- 1 year supervisory experience preferred.
- Experience in quality management systems is essential.
- ISO-13485 Lead Auditor certification or equivalent is essential.
- Experience working onsite developing / managing suppliers is essential.
- Lean Six Sigma yellow certification.
- Lean Six Sigma green certification preferred.
- Must have experience in multi-cultural, remote, virtual team environment.
Knowledge / Competencies
- Strong communication skills, verbal and written to effectively communicate across all levels of the organisation
- Critical thinking and strong analytical skills / problem solving skills
- Demonstrated collaboration, negotiation, and conflict resolution skills
- Thorough knowledge of current regulations, pertinent regulatory guidance and industry trends
- Must have experience in using PFMEA’s, Control Plans, & Process Flows
- Demonstrated ability to collaborate effectively with cross-functional teams
- Demonstrated experience with trending and analysis reporting
- Demonstrated leadership skills
- Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes
- Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality.
Regular travel to supplier facilities required, up to 70% of time.
Must be able to travel internationally.
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com
