Why RA/QA 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 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

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

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based 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.

Stryker is hiring a Associate Manager Quality Assurance (Hybrid) located in Ventura, California!

Workplace Flexibility: Candidate must reside within a commutable distance to Ventura, CA but is expected to be onsite at the facility multiple times/week. Relocation assistance is offered.

Who we want-

• Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures.

• Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

• Insightful advisors. Managers who lead strategy development and provide guidance to teams

What you will do-

• 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 organization’s 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 programs 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.

What you need-

Required

• Bachelor’s degree required.

• 6+ years’ experience in a Medical, Pharmaceutical, Bio-Medical/Pharma, Automotive or a highly regulated manufacturing environment.

Preferred

• Bachelor of Science or engineering is preferred.

• Experience with plastics/injection molding would be preferred

• Experience of successfully creating and managing a talented, engaged and performing team 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.

• 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.

$83,000.00 to $176,800.00 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.

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