Stryker
Product Field Action (PFA) Lead, (Hybrid)
Redmond, Washington · Contract
Sponsorship not specified$103k-$171kDetected 19 hours ago
StatisticsProject ManagementStakeholder ManagementNegotiationAuditingFDA RegulatoryMedical DevicesCommunicationCollaborationMicrosoft OfficeSharePointInternal AuditRegulatory Affairs
About the role
- Travel Percentage: 20% Stryker Corporation is an equal opportunity employer.
- Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
- Stryker is an EO employer - M/F/Veteran/Disability.
Responsibilities
- Establish and maintain standardized process and procedure for executing field action assessments and executions, including but not limited to investigations and identifying solutions.
- Lead and provide strategic direction to Senior Quality Assurance Engineers responsible for Product Field Action Assessments (PFAA), Non-Conformance (NC), and CAPA activities.
- Lead Product Field Action monthly Board review
- Develop strategies and plans for field actions in alignment with organizational goals and objectives.
- Identify potential risks associated with field action decisions and implement measures to mitigate them effectively.
- Monitor key performance indicators (KPIs) to evaluate the effectiveness of the field action process and implement improvements as necessary.
- Collaborate with internal stakeholders, such as PFA assessment and execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.
- Maintain a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.
- Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and safety of field action decisions over time.
- Support internal and external audit activities relating to the PFA process.
Requirements
- Bachelor's Degree in Science, Engineering, Quality, or a related technical discipline.
Nice to have
- Demonstrated Product Field Action (PFA) experience.
- Experience in Post-Market Quality and product field action processes.
- Prior project management experience.
- Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 requirements.
- Excellent interpersonal, collaborative teamwork, and negotiation skills.
- Experience utilizing quality and project management systems such as: TrackWise, Microsoft Office Suite, SharePoint, Visio
- United States of America Pay Ranges:
- Travel Percentage: 20%
Compensation
- $102,700 - $171,100 USD Annual
- View the U.S. work location and transparency guide to find the pay range for your location.
Benefits
- 4+ years of experience in a highly regulated quality, manufacturing, engineering, or medical device environment.
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