Stryker Senior CAPA Specialist in Burnaby, Canada
Requisition ID 30408BR
Job Title Senior CAPA Specialist
Group Global Quality and Ops
Division SGS Quality Assurance
Business Unit QA NA West
Business Function Quality Assurance
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
Senior CAPA Specialist
Stryker is one of the world’s leading medical technology companies and consistently ranked as one of the Top 100 Employers to Work For by Forbes. Together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including orthopaedics, medical and surgical, and neurotechnology & spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries around the world. For more information, please visit our website at www.stryker.com .
To learn more about why people love working at Stryker, check out this video:
We have an opportunity for a collaborative Senior CAPA Specialist (Sr. Quality Systems Specialist) who is passionate about coaching and guiding cross-functional team members through the corrective/preventive actions (CAPA) process. Through these interactions, you will gain wide exposure to all levels and all parts of the organization.
The Senior CAPA Specialist will be primarily responsible for the oversight of the CAPA process and procedures, and ensure it is compliant, effective, and efficient in dealing with quality issues. You will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues.
Working within the QMS team, under general supervision, ensure compliance to CAPA processes and procedures; responsibilities include:
Responsible for review and approval of NCs and CAPAs; review for completeness, accuracy, effectiveness, and timeliness. Review and approval of CAPA changes including extension requests.
Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
Ensure users provide the necessary rigor to the eCAPA system content, including maintaining a live document with all relevant evidence attached.
As Problem Solving Methodology expert, facilitate and coach NC and CAPA teams in the application of problem solving techniques, and promote its use and development; e.g. Human Error Reduction.
Subject Matter Expert on all related procedures, ensuring compliance to the relevant corporate procedures. Super user of eCAPA system.
Lead and execute the NC/CAPA Review Board forums. Lead multi-site forums and participate in global forums.
Manage and monitor site NC/CAPA KPIs including reporting requirements, and providing detailed updates and information in support of quality and business review forums; also liaise with other GQO sites to ensure compliance to global requirements and metrics are achieved.
Ensure adequate training is developed, maintained, and provided to all users of CAPA process and systems.
Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
Lead and/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
Lead/coordinate preparation, participation, and follow-up to Stryker Internal, Corporate, and third party compliance audits.
Bachelor or Masters Degree in Science, Engineering, or equivalent/related subject required.
Minimum of 2 years’ experience in the area of quality systems or engineering, or equivalent experience.
Minimum of 4 years’ experience in regulated environment (medical devices or aerospace) required.
Having a CAPA background; ownership of NC/CAPA preferred.
Strong knowledge of supporting Quality Systems (e.g. Audits, Management Review, Quality Planning).
Must possess strong communication, project management, and influencing skills, as well as have the ability to manage multiple tasks simultaneously.
Strong interpersonal skills.
Strong written and oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Highly developed problem solving skills; strong analytical skills.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Demonstrated ability to work independently.
Experience in working in a compliance risk situation.
High level of PC skills. Must be proficient with Microsoft Word, Excel, and PowerPoint
Some travel may be required.
Apply through our candidate portal at:
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