Manager, Quality Management Systems (Hybrid) (R459871)
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.Why join Stryker?
We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
Why regulatory affairs/quality assurance at Stryker?
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 Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
Stryker is currently seeking a Manager, Quality Management Systems (Hybrid) located in Arlington Tennessee (outside of Memphis).
The candidate will need to live within a reasonable commuting distance to our Arlington, TN facility. You will need to be in the office 2-3 days a week but will have the flexibility to work from home on the other days.
Who we want:
Dedicated achievers: People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do:
You will work within the QMS structure, with responsibility to ensure an effective and efficient quality management system is built and maintained, which includes, but not limited to the following:
- Oversee document control, change management, CAPA, QMS and calibration by setting strategic direction, clear objectives and expectations.
- You will foster a positive employee relations environment by promoting open communication, engagement and development of team members.
- You will develop strategic and global alignment of the QMS strategy with the campus, corporate and Global Quality Operations.
- You will be responsible for development of best-in-class QS practices and benchmark against industry leads, regulatory requirements and maintain the Quality Management System (QMS).
- You must be attuned to business needs ensuring that the QMS best practice is implemented and continuously reviewed to ensure compliance with all applicable regulatory requirements.
- You will be responsible for assessment and approval of change control of quality system (BPO/QA approval) per regulatory and internal system requirements.
- You will be responsible for oversight of the Training Processes ensuring training effectiveness and timeliness to ensure compliance.
- You will need to be knowledgeable on system integrations and contribute to development & generation of system requirements on a high level.
- Lead and report out on monthly Quality Assurance KPI updates.
- You will collaborate with sites ensuring continued accreditation to all regulatory bodies.
- You will support sites in all internal and external audit program, ensuring good relationships with notified bodies to manage certification status & changes.
What you will need:
- Bachelor’s Degree in Science, Engineering or related
- 10+ years of regulated industry experience, with a minimum of 3 years within the medical device industry
- 2+ years of people management experience
- Multi-site responsibility highly preferred
- Advanced degree preferred
- Experience in quality management systems is highly preferred
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
- Experience with third party audits
- Demonstrate technical knowledge of medical device product lines
- Strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously highly preferred
- Demonstrated written, verbal, listening, communication, and team-building skills
- Demonstrated ability to collaborate effectively with and lead cross-functional teams
- Demonstrated ability to effectively prioritize and manage multiple project workloads
- Demonstrated experience with trending and analysis reporting
- Demonstrated leadership skills
- Demonstrated process improvement and management skills
- Experience with recruiting, people development
- Ability to build and leverage influence across the organization
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com