Ashland, MA, United Kingdom
$70,000 - $100,000
3 months ago
Opportunity for someone with experience in Medical Devices to work for a fast-paced growing manufacturer of Medical Devices who are successfully supporting the fight against COVID-19 with their expertise and ability to supply the continental US with efficient and effective testing kits.
This leader in their field are looking for a highly motivated and adaptable individual to drive and streamline quality performances, determine and shape quality processes, and collaborate with this versatile team in achieving company goals
Principal Duties and Essential Functions:
- Maintain Quality Database and all ISO documents under ISO:9001 and ISO:13485
- Lead quality process improvement projects and participate in management reviews
- Assist in customer, ISO, and FDA audits Customer Quality Assurance Plans
- Assist in development and implement Quality Plans
- Work with operations to achieve quality realization using continuous improvement tools
- Recommend training topics to the QM
- Assist in quality training to ensure that employees meet the standards.
- Conduct monthly system audits
- Conduct and maintain daily audit process
- Management Review
- Work with QM to ensure that action items are effectively completed and audited
Qualifications/Skills that are REQUIRED
- Bachelor’s degree or equivalent experience required
- 2 - 5 years in Quality Management with previous Medical Device manufacturing ISO:13485 experience.
- Technical Quality Systems knowledge including Statistical Process Control (SPC), Quality Function Deployment (QFD)
- Lean, Six Sigma, Kempner Tregoe problem solving is highly desirable
- Strong interpersonal skills and the ability to interact with internal and external customers are essential
- Experience with medical product manufacturing (GMP, BPR, FMEA, Risk Assessment)
- Working knowledge of ISO 9001, ISO13485 and FDA regulations
- Knowledge of Converting
- Experience with FDA inspections
The company conducts pre-employment drug testing.