Director, Quality Assurance and Quality Control

Director, Quality Assurance and Quality Control
  • Competitive
    HOUR
  • Permanent
  • Woburn MA, US Woburn MIDDLESEX US 01801
Job Ref: JO000120277
Sector: Clinical
Sub-sector: Quality
Date Added: 14 July 2021


SRG is a global staffing and consulting firm and we are looking for a Director, Quality Assurance and Quality Control for our client in Woburn, MA.

Provides QA/QC leadership across all departments, giving input to senior management, for product and process improvements. Develops a strong culture of quality in the organization. Reports directly to CEO.

Responsibilities:

  • Further develop and drive changes to a Quality Management System (QMS) that is compliant, effective, and quickly responds to the needs of a diverse and evolving product line
  • Lead the upgrade of an organization and QMS to ISO certification and accommodate FDA level design and manufacturing
  • Manage a group QA/QC professionals and mentor, motivate, and organize the teams
  • Develops quality standards and protocols for a rapidly growing organization with diverse customer products and ensures that all employees are trained and comply with these policies.
  • Responsible for maintaining and improving a quality system and team for both US and European operations.
  • Manages quality assurance, quality control, supplier quality, incoming inspection, calibration, complaint handling, software validation, and document control.
  • Plan, coordinate and direct quality strategies for new and existing products, including raw materials, materials in process, and finished goods
  • Initiate, implement and maintain ISO 9001 standards to achieve certification/recertification.
  • Be an ‘ambassador’ for quality assurance and drive quality awareness and improvement.
  • Direct investigations and implement corrective actions to resolve any complaints or non-compliance.
  • Develop and implement a Quality Management System (QMS) that is compliant, agile, and effective, responds to the needs of an evolving product line, and integrates with the company’s near-term and long-term strategies.
  • Be comfortable working with employees from all departments and interfacing with customers regarding quality plans and audits
  • Needs to act as a hands-on team leader and mentor to subordinates.

Qualifications:

  • Bachelor’s degree in Science or Engineering.
  • 10+ years quality systems/regulatory compliance experience, preferably with in-vitro diagnostics or Life Sciences.
  • Experience with laboratory instrumentation, consumables, and/or reagents is a plus.
  • 5+ years managing a quality organization with a diverse product portfolio.
  • Expertise with ISO 9001 and GMP standards and practices
  • Experience with and ability to develop process within an electronic quality management system (eQMS) in a regulatory environment a plus
  • Ability to implement, prioritize, and direct multiple projects simultaneously
  • Demonstrates leadership ability and experience has excellent people management skills
  • Strong written and verbal communication skills

#LI-KS1

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
31/07/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Kayla Sanford

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