Stryker CAPA Analyst (Quality Systems Associate) in Burnaby, Canada
Requisition ID 28441BR
Job Title CAPA Analyst (Quality Systems Associate)
Group MedSurg and Neurotech
Business Unit San Jose
Business Function Regulatory Affairs
Employment Category Full Time
Percent Travel Required None
Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. We are an EO employer – M/F/Veteran/Disability.
Job Description / Information
At Stryker , customers and patients are at the heart of everything we do. We proudly stand behind our quality products. If you are passionate about improving quality in production, and want to grow with a growing company, we have the right opportunity for you.
We have an opportunity for a collaborative CAPA Analyst (akin to Quality Analyst or Quality Systems Associate) who is passionate about coaching and guiding cross-functional team members through the corrective/preventive actions (CAPA) process. Through these interactions, the CAPA Analyst will gain wide exposure to all levels and parts of the organization.
The CAPA Analyst is responsible for reviewing and evaluating CAPA and the CAPA effectiveness program, as well as communicating CAPA status to cross-functional departments and management.
Participate in identifying the need for a CAPA to address non-conformances.
Develop / review metrics for adverse trending analysis of non-conformities.
Support cross-functional teams in the investigations of non-conforming events and CAPA implementation.
Review and evaluate CAPAs associated with non-conformance and regulatory audits.
Review CAPAs to determine their effectiveness.
Develop and provide metrics for CAPA status.
Ensure on-time completion of CAPAs.
Identify opportunities for continuous improvement.
Interact with FDA and other regulatory agencies, as required.
Create / revise SOPs associated with CAPA systems.
Provide training for compliance to CAPA procedures.
B.S. / M.S. in engineering or sciences (mechanical, electrical, industrial, software, computer, biology, physics, chemistry, etc. )
1 to 2 years experience
Strong ability to influence, motivate, and drive action
Ability to convince others to invest the time and energy on activities that are outside their normal or ideal workflow
Ability to balance firmness with diplomacy and supportiveness
Able to read and interpret engineering schematics/drawing/prints, preferred
Commitment to excellence and high standards
Excellent English written and oral communication skills
Excellent organizational, problem-solving, and analytical skills that lead to sound, timely decisions
Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
Ability to deal effectively with a diversity of individuals at all organizational levels
Working knowledge of data collection, data analysis, evaluation, and scientific method
Must be able to analyze and resolve non-routine product issues using independent judgment with the assistance of Quality and Engineering support when required
Preferably have knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.)
Willingness to train others in quality assurance/GMP-related topics
Proficient with Microsoft Office
All 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