Staff Engineer, Quality Assurance
4 weeks ago
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:
Basic Function:
Manufacturing Quality Engineer role is to implement a unified approach to Quality in Stryker with the intent to deliver high quality products and services in a manner that meets the high standards held by Stryker.
Responsibilities:
This role will provide support to the Site Quality team to ensure compliance to technical, regulatory and Stryker requirements.
Executing Change Managements & Manufacturing Changes associated with Machine moves, Process changes, validation updates.Executing Production part approval process for any change request.3-5 Years of Experience of Handling team.SME for Validation (Validation PSPs, EQ, MSA execution)NC/ CAPA for internal Manufacturing issues (Clean, Pack, Label, Gage)Driving Internal Continuous Improvement projects at Site.Executing Gage Evaluation from QT's & focus on Gage/ fixture Updates & Development.Reviewing & providing inputs on Supplier Material Certificates.Ownership for site quality performance and measurement including KPI’s and participate in supplier performance reviews.Support quality issues with site & partner with Internal Customers; Lead effective supplier containment and corrections/corrective action.Provide support to Internal/ External Customer groups on compliance issues related to assigned sites.Participate in cross- functional teams in the development of new products or changes related to current products in meeting customer requirements. Applies sound, systematic problem-solving methodologies (5Why, DMAIC, 8D, C&E) in identifying, prioritizing, communicating, and resolving quality issues - NC & CAPA. Support on Internal (Site) & External (Supplier) Engineering Change Management & participate in as required in CFT in conjunction with key stakeholders.Promote the use of continuous improvement methodologies such as Lean, Six Sigma, Poka- Yoke (Error Proofing), Measurement System Analysis (MSA), Statistical process control (SPC) and Process Failure Mode and Effects Analysis (pFMEA).Professional Requirements:
(Electronics/Electrical/Mechanical) with 10-13 years of experience in Quality / Engineering / Manufacturing environment, preferably from medical industry with ISO 13485 auditor certification is a must. Trained on Trackwise enterprise system, PLM would be an advantage. Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)Technical Competencies
Supplier Quality Processes/ Tools - Working knowledge of basic and advanced Quality tools such as; Six Sigma, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, Kaizen, Lean Manufacturing etc. Executes/ Masters & implements/ improve all supplier quality tools/ Processes. Trains supplier in these tools effectively. Commodity Domain Knowledge – Strong Knowledge & understands technology, regulatory requirement related to product, system & services. Determine supplier technical abilities based on these knowledges.About StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at
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