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.
- 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.
- 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
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.
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