Associate Manager, Quality Assurance (Hybrid)

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 an Associate Manager, Quality Assurance in Franklin, TN!

As a leader of a dedicated Quality Operations team this manager will 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

Who we want-

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
• Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
• Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

What you will do-

• 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.
• Assist in developing and supports local and global strategies for the Quality Operations function.
• 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.
• 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:
• 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.
• 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.
• 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.
• Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NC & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
• Corporate and GQO requirements, Quality System Regulations and standards.
• Leads Quality 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.
• 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.

What you need-

Required

• 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.
• Minimum of 6+ years' experience in a Medical Device, Pharmaceutical, Bio-Medical/Pharma, or regulated manufacturing environment.
• Must be able to work in a team & individual environments, interacting effectively at all levels, and across all functions with ability to develop organizational relationship and build trust.
• Expert working knowledge of regulatory requirements, standards and regulations, with experience of managing inspections/audits by the FDA and other bodies.
• The candidate must be highly organized, disciplined, and be able to demonstrate their ability to meet deadlines as well as exhibiting initiative and independence.
• Bachelor's degree in engineering or in a Science discipline required.
• Ability to implement organization and functional strategy. Ability to initiate and implement change with a demonstrated track record (at individual level or team level)
• Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools.

Preferred

• Experience of successfully creating and managing a talented, engaged and performing team is advantageous.
• Masters degree in Business Management or MBA is preferred

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