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Quality Assurance Manager
4 months ago
Anodyne Surgical is seeking a skilled and detail-oriented Quality Assurance Manager to join our team. As a Quality Manager, you will play a crucial role in ensuring the quality and compliance of our medical devices. You will be responsible for conducting quality inspections, managing quality assurance processes, analyzing data, and implementing quality control measures.
About Anodyne Surgical
Anodyne Surgical is a privately held, mid-size manufacturing company specializing in producing disposable ophthalmic medical devices for eye surgery - typically cataract removal. We operate in our climate-controlled 13,000-square-foot factory/office building located near the intersection of I-64 and Highway K in O'Fallon, MO. Our high-volume products are modified, and custom cannulas are adapted for the unique needs of eye surgery. We offer our customers and distributors a wide range of custom products and rapid order fulfillment.
Duties
- Quality assurance support in the design and development support of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan including verification and validation activities.
- Analyze data to identify trends and areas for improvement.
- Oversight of quality inspections for incoming materials, in-process production, and finished medical devices.
- Develop and implement quality assurance procedures and processes for compliance with ISO 13485, CGMP, FDA (21 CFR, 21 CFR part 803, 21 CFR part 806) regulations, MDSAP, EU MDR.
- Investigate root cause analysis, nonconformances, and complaints
- Collaborate with cross-functional teams to address quality issues and implement corrective and preventative actions.
- Conduct internal audits to ensure proper compliance with procedures in accordance with regulations and standards.
- Participate in external audits conducted for certification and assist with regulatory inspections (domestic or foreign) or audits conducted by customers, notified body.
- Contribute in design/change control and risk management activities.
- Provide guidance and support to manufacturing teams regarding quality control measures.
- Develop and maintain documentation related to quality processes, procedures, and specifications.
- Assist with project management activities related to quality improvement initiatives.
- Strong knowledge of quality inspection techniques and methodologies.
- Works well under pressure and can honor deadlines.
- Proficient in quality system management principles and practices.
- Ability to analyze data using statistical tools and techniques.
- Knowledge of ISO 13485, CGMP, FDA (21 CFR Part 820, 21 CFR part 803, 21 CFR part 806) regulations, MDSAP, and the interrelation of QMS with EU MDR.
- Experience conducting quality audits.
- Excellent problem-solving skills with the ability to identify the root causes of issues.
- Strong attention to detail and accuracy.
- Effective communication skills, both verbal and written.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in Microsoft Office products.
- Salary based on experience
- 401(k)
- Health, Dental and Vision Insurance
- 11 Paid Holidays
- Paid Time Off
- Qualifications
- Bachelor of Science in Quality discipline or related science or data science degree
- CQE is a strong plus or other quality certification (CQI, CQM, CQA, CQT, etc.)
- 3-5 Years Minimal Experience
- Experience with ISO 13485, ISO 14971, GDP, CGMP, FDA (21 CFR 820, 21 CFR part 803, 21 CFR part 806) regulations, MDSAP
