Regulatory Compliance Program Manager in Bothell, WA at Volt

Date Posted: 5/21/2020

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Bothell, WA
  • Duration:
    N/A
  • Date Posted:
    5/21/2020
  • Job ID:
    227042
  • Contact Name
    Volt Branch
  • Phone
    425.629.7493

Job Description

VOLT is looking for a Senior Regulatory Compliance Program Manager to become the newest member of our client’s Quality Assurance Team located in our Bothell, WA headquarters for a Full-time role.

The Sr. Regulatory Compliance Program Manager is responsible for providing oversight of quality system improvement, analysis of data, and CAPA processes. The Sr. Regulatory Compliance Program Manager will ensure the effectiveness of the Quality System by developing and implementing effective processes and tools to identify, investigate, report, measure, and respond to compliance issues.

Principal Responsibilities:

  • Support Director of Quality Assurance and Regulatory Compliance in establishing and implementing an effective and efficient global quality system to ensure sustainable compliance to international medical device regulations and internal procedures.
  • Assist in the implementation of quality system processes, procedures, and computerized systems that support design, development, manufacturing and distribution of MDSAP-compliant products.
  • Support Director of Quality Assurance and Regulatory Compliance in implementing and monitoring effective trending of quality metrics.
  • Manage the Corporate Quality Systems process for CAPA.
  • Manage the Corporate Quality System for Field Corrective Actions / Recall
  • Manage the Corporate Quality Improvements process and Analysis of Data.
  • Develop, implement, and maintain procedures and work instructions to support the administration of the quality system.
  • 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.

Knowledge, Skills, and Abilities:

  • Bachelor’s Degree in a related discipline.
  • Minimum 5 years’ experience with Medical Device CAPA required
  • Experience successfully executing Global Field Corrective Actions preferred.
  • Experience with working in a global environment with demonstrated strong collaboration skills across business units required.
  • Expert knowledge of international CAPA regulations and guidance.
  • Expert knowledge of the US Quality System Regulations and ISO 13485.
  • Experience as a Kaizen Facilitator with demonstrated results executing Transactional Process Improvements (TPIs) required.
  • Lean Six Sigma experience required, Black Belt preferred.
  • Strong training skills, ADDIE experience preferred.
  • Strong analysis of data skills, experience with Minitab and PowerBI preferred.
  • Experience with Epicor ERP or MasterControl EQMS preferred.
  • Strong desire to work within a collaborative, productive, and empowered team.

VOLT is an Equal Opportunity Employer