This position is responsible for all RA/QA functions and responsibilities to insure compliance to all the Medway facility's QMS in accordance with ISO13485:16. This includes manufacturing, packaging, testing and distribution of medical devices.
Our client designs, develops, manufactures, and markets a broad range of medical devices worldwide. Headquartered in the Metro-west of Boston, this manufacturer has tripled its size since over the past 20 years.
- Provide RA/QA leadership across key departments, giving input to senior management, for new products and suggestions for sales and marketing.
- Train company employees on compliance with quality system standards such as 21 CFR 820 and ISO 13485.
- Participate with the management team in developing and implementing relevant business and strategic plans.
- Ensure company is regulatory inspection (FDA, Notified Body, international regulatory bodies, corporate) ready at all times.
- Plan, coordinate and direct regulatory strategies for new products.
- Manage regulatory affairs, quality control, quality assurance, calibration, complaint handling and document control staff.
- Develop and implement quality system management strategies and plans to include resources, systems, timelines and financials that support, contribute to and integrate with company's annual and long term business strategy.
- Direct investigations to resolve complaints and non-compliance instances. Implement corrective action plans to correct non-compliance issues.
- B.S. degree is required. BS Degree in Engineering is preferred.
- Local candidates only, no relocation is offered.
- Extensive working knowledge of ISO 13485
- 10+ years regulatory compliance/quality systemss experience with medical devices, with 3 - 5 years Sr Manager or Director experience
- Extensive experience working with the FDA regarding inspections, submissions and follow up.
- Familiarity with FDA and international new product registration requirements.
- Excellent benefits
- Visibility to senior leadership; reports to General Manager with a dotted line to the CEO
- Manages all QA/RA functions.
- 10% bonus
- Competitive base salary
- Market leader in medical devices
- Strong culture of Quality within the organization
- Please apply now and your resume will be reviewed within 48 hours!