Associate Manager - Quality Control

COVID-19 vaccination requirements

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, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

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

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.
• Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
• 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.

What you will do-

• Responsible for Supervising and training QC personnel, directing the flow of product in quality inspection area.
• Establishing and enforcing procedures and policies to ensure completion of appropriate testing and documentation according to company policy, cGMPs, and regulatory requirements.
• Administering in-process and finished products through communication with Marketing, Engineering, QA, Purchasing, Production and Regulatory Affairs.
• Read, understand, and comply with FDA Regulations, ISO requirements, and company standard operating procedures.
• Maintain the quality production program to ensure conformity of materials and final products to quality and regulatory standards.
• Coordinate corrective actions and resolve quality concerns for any product or component
• Write, review and/or revise all departmental SOPs and work instructions and ensure compliance.
• Participate in establishment of uniform corporate quality procedures.
• Produce written reports of special projects as needed.
• Provide training, supervision and technical guidance to all QC employees.
• Leading process improvement initiatives across the department.
• Identify relevant quality-related training needs.
• Review and approve outgoing product.
• Complete various forms and documentation as related to reporting inspection results.
• Communicate both verbally and written with coworkers and management regarding procedures, inspection, requirements and other elements of quality assurance.
• Perform housekeeping duties to maintain a clean and safe work environment.
• Inform managers of any potential problems.
• Interact professionally and diplomatically with managers, co-workers, and suppliers
• Establish work priorities for the QC department.
• Conduct performance reviews for the QC department.

What you need-

• Bachelor’s degree in Engineering discipline or equivalent is required.
• Must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge, skill, and/or ability required.

• Minimum of 6 years of quality or engineering related experience required.
• Minimum of 3 years of management or supervisory experience required.
• Ability to read and understand technical drawings, customer specifications, and work.
• Ability to routinely travel 30% of the time and coordinate a flexible schedule.
• Experience with ISO and /or GMP procedures and regulations.
• Background in medical device manufacturing, machining, and design environment.
• Excellent interpersonal, written, and verbal communication skills and group facilitator process skills.
• Computer proficiency in all Microsoft Office applications.
• Strong organizational and time management skills.
• Proficient in use of software/ technology to develop and present data.
• Show initiative, resourcefulness, creative thinking, and adaptability.
• Ability to follow procedures and maintain quality of products at all time.
• Must be detail orientated, self-motivated, and able to multi-task.
• Experience with ANSI Y14.5 Geometric Tolerances.
• Experience with ANSI / ASQC Z1.4 Sampling Plan.
• Working knowledge of GMP compliance for Class II Medical Devices.
• Hands-on experience with micrometers, calipers, dial and digital indicators, optical comparator, ring gauges, pin gauges, and thread gauges.
• Understanding of thread specifications and classifications.
• Basic understanding of machining processes.
• Familiar with cGMPs.
• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

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