Service Quality Engineer (Hybrid)

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• 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.

• Support day-to-day Service operations and addressing line requests by acting as Subject Matter Expert for Quality and Manufacturing standards to ensure compliance and high-quality performance of Service processes.
• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Support continuous improvement initiatives with suppliers and in-house teams to improve Quality, reduce cost, and increase efficiency and effectiveness of Service processes.
• Own, maintain and improve Service line(s) layout, setup, configuration, and fixturing.
• Own internal and supplier non-conformances and manage the timely disposition and closure of NCRs/NCs Own or support identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.
• Communicate/collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as required.
• Engage in the development and improvement of Service processes for existing products.
• Assess and implement internal and supplier proposed changes. Performs PPAP activities for supplier changes.
• Plan and execute equipment/process validation and reporting.

• Bachelor's degree in a Science or Engineering Degree is required.
• 0+ years of experience working in a regulated environment.

• Demonstrated mechanical/electrical problem-solving skills.
• Electrical background desired.
• QE or equivalent course work / experience is desirable.
• Preferred to have knowledge of applicable domestic and international regulations and quality system standards - FDA QSR, MDD, ISO13485, ISO9001, etc.
• Lean Six Sigma or other problem-solving methodologies is a distinct advantage.
• Previous experience in a regulated environment desirable.
• Proficient in understanding of Medical Device manufacturing processes is desirable.
• Working knowledge of MS Word, MS Excel, MS Visio, and MS PowerPoint.
• SAP experience is preferred.
• Minitab experience is preferred.

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.