Staff Engineer
4 weeks ago
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:
Position summary:
This position will be responsible to provide Quality Engineering leadership to Product Development projects and ensure compliance to regulations, procedures, and standards applicable to Stryker Spine. Lead and participate in continuous quality improvement activities. Minimal supervision.
Essential duties & responsibilities: (detailed description)
Manage and lead Risk Management activities throughout the Product Development Process.Lead the development of new and improved quality processes; streamline existing processes using knowledge of six sigma techniquesSupporting data requests and lead the creation of post market documentation as needed:Post-Market health risk assessments (PMHRA)Product Field Action Assessments (PFAA)Product Historical Performance reports (PHP)Post-Market Safety Reports (PSUR)Post-Market Surveillance Reports (PMS)Country specific requestsPerform trend analysis and drive actions/product improvement if necessaryAddress complaint inquiries submitted to Post Market Surveillance by internal and external customersCommunicate complaints to notify bodies is necessaryLead and/or assist in resolving complex nonconformities (NC) and corrective/preventive actions (CAPA).Collaborate across functions and other Stryker Divisions to enhance processes and drive efficiency.Support internal and external auditsProvide mentoring and leadership to junior EngineersOther duties as assigned (may include, but not limited to)Support Complaints IntakeSupport Complaints ApprovalsEducation & special trainings:
Bachelor’s Degree in Engineering or other relevant field of studyCertified Quality Engineer (preferred)Advanced degree (preferred)Six Sigma Green Belt Certification/training (preferred)
Qualifications & experience:
5+ years’ experience as a Quality Engineer (QE) or relevant role in a cross-functional project team.Experience with the medical device product development life cycle, including design and process verification & validation.Demonstrated applied knowledge of:FDA and international medical device regulations/standards/directive applicable to spinal implants and instruments (ISO 13485, ISO 14971, 21CFR820, 93/42/CE, cGMPs)Risk Management – Risk Analysis, Evaluation, and ControlAdvanced Quality tools such as Top-Down Risk Assessment, Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, Mistake Proofing/Poka Yoke.Demonstrated ability to effectively work cross functionally with other departments including Research & Development, Regulatory Affairs, and Marketing. Demonstrated problem-solving and troubleshooting skills, including root cause analysisDemonstrated interpersonal and communication skills.Demonstrated ability to exhibit a positive, energetic approach to teamwork.Demonstrated ability to advocate product excellence and quality.Other duties as assignedAbout 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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