What are the responsibilities and job description for the Quality Director position at Merit Manufacturing?
QUALITY DIRECTOR:
Overview of The Role:
The Quality Director at Merit Manufacturing is responsible for maintaining world-class quality systems that ensure lab and manufacturing procedures deliver consistent product quality.
Essential Duties and Responsibilities
- Develop and enforce all company quality policies and train on practices, including cGMP and SOPs.
- Monitor internal processes to proactively improve repeatability and eliminate errors.
- Ensure all testing delivers raw materials, batches and finished products that comply with established standards and specifications.
- Implement customer-required testing and approval procedures in a way that creates satisfaction and trust.
- Review and understand customer quality agreements; ensure alignment and adherence.
- Manage all external testing with 3rd party labs to deliver lowest cost with the best response time.
- Ensure all laboratory practices and equipment are maintained in a way that generates reliable results.
- Ensure effective and timely execution of internal and external audits; ensure timely resolution.
- Drive continuous improvement in all processes to improve compliance and quality and minimize waste.
- Ensure all non-conformances and complaints are handled efficiently and accurately.
- Lead internal investigations in a thorough and timely manner, and results in positive customer interaction
- Guide the development of robust corrective actions to permanently resolve root causes of issues affecting quality.
- Report on Quality activities on a regular basis to the Executive team, ensuring accurate and timely reporting of KPIs.
Supervisory Responsibilities:
- Lead the quality team by creating and communicating a department vision that aligns with company strategies.
- Develop, coach and train the quality team in a way that engages the employees and provides a career path.
- Ensure clarity of role and accountabilities using robust job descriptions and performance reviews.
- Correct, redirect and mentor in a way that causes continual improvement.
Experience Needed:
- Bachelor’s degree (B.A./B.S.) in related field or equivalent. Master’s degree is beneficial.
- 5 years working in a quality leadership role in a regulated environment.
- In-depth understanding of compliance, quality assurance, quality control and microbiology processes.
- Proven experience managing regulatory requirements and facilitating audits.
What you get for your Hard Work:
Pay: (Depending on Experience Level)
Benefits:
- Healthcare
- Dental
- Flexible Time Off Policy
- Performance Bonus Opportunities
- Year End Bonus Opportunity
- Company events
Equality:
Merit Manufacturing is committed to the full inclusion of all qualified individuals. All qualified applicants will receive consideration for employment without regard for race, religion, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information.
