CAPA Manager (113) Bothell, Washington
CAPA Manager - Verathon®
Verathon® is looking for a CAPA Manager to become the newest member of our Quality Assurance Team located in our Bothell, WA headquarters. The CAPA Manager is responsible for providing oversight of the corrective action process for the Bothell WA Verathon manufacturing site by developing and implementing appropriate improvements to drive product and process improvement across the global business in order to ensure compliance in a regulated industry. The CAPA Manger will ensure the effectiveness of the Quality System by developing and implementing intuitive processes and assuring consistency in identifying, investigating, reporting, measuring, and responding to compliance issues through development and implementation of consistent tools, training programs, and actionable metrics.
Corporate Quality Systems process owner for the global corrective and preventive action process.
- Facilitate (weekly, bi-weekly/monthly) Corrective Action Board (CAB) meetings.
- Develop effective CAB presentations and maintain meeting minutes.
- Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of events.
- Analyze trends to monitor the effectiveness of the CAPA process and drive remediation for improvement.
- Escalate issues to senior management in a timely manner.
- Monitor investigations and approvals to ensure that all the required information is captured and documented with relation to events.
- Provide training and system awareness on a global level.
- Participate in establishing strategic direction for quality system activities that are aligned with business and quality initiatives and in compliance with all regulatory requirements.
- Develop, implement, and maintain procedures and work instructions to support the administration of the quality system.
- Recommend and implement quality system processes improvements driven by new regulations, industry standards, new technologies, and internal business needs.
- Maintain current knowledge of, and compliance with, the full range of related quality systems, technology, regulatory requirements, and related policies and procedures.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement
- Ensure adequate training is conducted and competency is maintained among key process stakeholders.
- Participate in external and internal regulatory compliance inspections
- Participate in Management Review meetings as required.
Knowledge, Skills, and Abilities:
- 4-year degree (Engineering preferred)
- 5-8 years of CAPA experience, specifically related to 21CFR 820.100 preferred
- Minimum of 5 years’ experience in the medical device industry
- Expert knowledge of the US Quality System Regulations and ISO 13485
- Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units
- Strong statistical and root cause analysis background.
- Excellent written & verbal communication skills.
- Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
Verathon is a wholly owned subsidiary of Roper Industries, an acquisitive S&P 500 and NYSE listed diversified growth company. Verathon is headquartered in the greater Seattle area, in Bothell, Washington, and has 7 international subsidiaries in Canada, Europe and Asia. The company designs, manufactures, distributes and markets reliable, state-of-the-art medical devices and services to the health care community that offer meaningful improvement in patient care. Our largest brands, BladderScan and GlideScope, have achieved worldwide recognition as the number one leader in their respective markets. Verathon is a financially sound company with consistent growth and performance even during down market cycles. We have a strong pipeline of new products for multiple areas of discipline within the heath care industry.
Verathon was acquired by Roper Industries (US Ticker symbol ROP) in December 2009 as a platform for future acquisitions leveraging the talented management team and extraordinary channel development in developed country markets.
Verathon offers competitive compensation and a complete benefits package to full-time employees including company sponsored health plan, 401k with match, wellness and tuition reimbursement and the advantages of an environment that supports your development and recognizes your achievements.
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.