Manager, Quality Assurance in Salt Lake City, Utah

Why RA/QA at Stryker?

Are you curious about working for a world firm the place you may work throughout capabilities and on a wide-variety of tasks? As a member of Stryker’s RA/QA workforce, that’s precisely what you’ll do! Right here, we offer our RA/QA workforce the chance to be taught new issues, in addition to limitless development alternatives! In case you are concerned with working at one of many World’s Greatest Workplaces, apply now !

Want one more reason to use? Listed here are 10 causes to affix our Regulatory Affairs/High quality Assurance workforce : https://www.strykercareersblog.com/publish/10-reasons-to-join-strykers-regulatory-affairs-team

We’re proud to be named one of many World’s Greatest Workplaces and a Greatest Office for Variety by Fortune Journal! Be taught extra about our award-winning group by visiting stryker.com

Stryker is hiring a Supervisor, High quality Assurance in Salt Lake Metropolis, Utah , supporting Neurovascular! On this position, you can be accountable to guide and handle a bunch of High quality professionals to make sure a excessive degree of High quality Administration System and regulatory compliance within the plant. This place can be answerable for High quality Administration System implementation, supporting Administration Assessment, coordinating third celebration audits (FDA, ISO, and so forth.) and administration of the operations high quality engineering operate. Serves as deputy Administration Consultant within the absence of the location head of High quality.

Who we would like:

• Purpose-oriented orchestrators. Individuals who can successfully coordinate and focus the work of expert workers towards an essential aim, prioritizing the proper actions that result in success.

• High quality-focused workforce drivers. Individuals who push their workforce to ship the very best high quality merchandise and options in a well timed method.

• Community builders . Managers who construct connections with different groups and divisions and coordinate cross-functional collaboration.

What you’ll do:

• Management of a excessive performing high quality workforce, that gives direct assist and technical steerage / route to the operational and practical areas on web site, fostering an surroundings of proactive and steady enchancment method to High quality.

• Be sure that the group’s conformance and dedication to producing merchandise meets or exceeds buyer necessities and the related regulatory requirements.

• Drive an surroundings of compliance inside Stryker by working with all operate managers and their assist employees to outline anticipated high quality requirements and the roles/tasks within the upkeep of those requirements.

• Champions a constructive worker surroundings by selling open communication, engagement and growth of workforce members. Promotes a tradition of belief, flexibility, teamwork and inclusiveness, making certain all related High quality capabilities (e.g. Shared Companies High quality, Provider High quality) are included in determination making processes as a part of steady enchancment, drawback fixing and tasks.

• Selects competent expertise and helps the event of their future potential. Ensures efficient coaching and efficiency administration of the groups.

• Ensures the location(s) maintains continued certification to all regulatory our bodies. Performs a lead position in all inside and exterior audit applications resembling Company, notified physique & FDA audits.

• Ensures efficient administration and management of product/course of deviations together with these of suppliers for all launched product and for the implementation of efficient corrective motion when non-conformances come up. Manages product & affected person threat.

• Develop a high quality planning pipeline of high quality enchancment actions together with initiatives to extend product high quality, NC & CAPA decision, cut back price, lower in-efficiencies and enhance threat administration.

• Oversight and accountability to make sure web site maintains adherence to High quality KPIs efficiency indicators and takes well timed motion to deal with hostile developments and deviations. Constantly displays and partakes in world boards to evaluate alternatives for enchancment.

• Foster robust collaboration on a world scale by taking part in and main cross practical and world course of enchancment initiatives.

• Has a strategic view in figuring out world alignment and creating methods for best-in-class practices and benchmark in opposition to business leads and regulatory necessities for the High quality operate.

Required:

• Bachelor’s diploma required. Engineering, High quality Assurance, or associated scientific self-discipline most popular.

• 8+ years’ expertise within the medical system, pharmaceutical, and/or regulated business.

• 2+ years of administration expertise.

Most popular :

• Demonstrated use of High quality instruments/methodologies and undertaking administration expertise.

• Expertise managing a workforce. Administration {of professional} degree high quality employees most popular.

• Demonstrated capability to successfully lead cross-functional/cross-plant undertaking groups utilizing related undertaking administration instruments resembling Microsoft Mission.

• Demonstrated expertise in creating high quality administration methods; design and growth of coaching applications/programs; lean documentation; and Six Sigma methodology.

• Demonstrated auditing expertise in medical system or different regulated manufacturing surroundings (biotech, pharma, navy/area).

• Utilized understanding of 21 CFR 820, MDD, MDR, ISO 13485 and relevant laws.

• Demonstrated capability to successfully advocate a strategic high quality methods method and lead the group to compliance.

• Demonstrated capability to work successfully with numerous work teams to guarantee conformance to regulatory necessities, inside processes, and insurance policies.

• Demonstrated management capability and expertise.

• Demonstrated PC proficiency. Demonstrated organizational and written/verbal communication expertise.

• Demonstrated capability to self-motivate

• Demonstrated capability to successfully work with others in numerous coordinate disciplines and on multi-national groups.

• Demonstrated capability to prioritize duties in a deadline-driven surroundings.

About Stryker

Our advantages:

• 12 paid holidays yearly

• Well being advantages embrace: Medical and prescription drug insurance coverage, dental insurance coverage, imaginative and prescient insurance coverage, vital sickness insurance coverage, accident insurance coverage, hospital indemnity insurance coverage, customized healthcare assist, wellbeing program and tobacco cessation program.

• Monetary advantages embrace Well being Financial savings Account (HSA), Versatile Spending Accounts (FSAs), 401(okay) plan, Worker Inventory Buy Plan (ESPP), fundamental life and AD&D insurance coverage, and short-term incapacity insurance coverage.

For a extra detailed overview of our advantages or day off, please comply with this hyperlink to be taught extra: US Stryker worker advantages (https://cdn-static.findly.com/wp-content/uploads/websites/1427/2023/09/20143933/US-Stryker-Worker-benefits.pdf)

About Stryker

Stryker is likely one of the world’s main medical know-how corporations and, along with its prospects, is pushed to make healthcare higher. The corporate gives progressive services in Medical and Surgical, Neurotechnology, Orthopaedics and Backbone that assist enhance affected person and healthcare outcomes. Alongside its prospects all over the world, Stryker impacts greater than 130 million sufferers yearly. Extra info is on the market at stryker.com. (http:)

Know somebody at Stryker?

Remember to have them submit you as a referral previous to making use of for this place. Be taught extra about our worker referral program on our referral web page (https://careers.stryker.com/referrals/)

Stryker is pushed to work along with our prospects to make healthcare higher. Staff and new hires in gross sales and discipline roles that require entry to buyer accounts as a operate of the job could also be required, relying on buyer necessities, to acquire numerous vaccinations as a vital operate of their position.

Stryker Company is an equal alternative employer. Certified candidates will obtain consideration for employment with out regard to race, ethnicity, colour, faith, intercourse, gender identification, sexual orientation, nationwide origin, incapacity, or protected veteran standing. Stryker is an EO employer – M/F/Veteran/Incapacity.