Job Description
This full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.
This individual will lead our Supplier Quality Engineering team in the qualification and monitoring tasks for commercial and new business development product lines. They will work with external suppliers, internal supply chain, and department stakeholders to improve process capability, ensure on-time delivery, and drive quality improvements by monitoring, trending, and critically reviewing supplier performance data.
This is a hybrid role, with the option to work primarily remote depending on your day's schedule. Occasional travel to conduct vendor audits will be required.
In this critical engineering leadership role you'll have the opportunity to:
- Monitor and measure supplier performance and implement supplier corrective actions
- Perform external vendor audits
- Maintain Approved Supplier List and manage supplier approval activities
- Administer technical investigations and corrective action programs to identify non-conformance trends, resolve recurring quality problems, and improve Supplier Quality
- Evaluate and recommend sampling plans for receiving inspection based on confidence limits, process capabilities, and manufacturing/inspection methods/equipment
- Maintain and improve quality systems
- Facilitate or participate in risk analysis for quality system processes
- Review and approve New Documents and Change Orders
- Facilitate the personal and professional growth of team to meet future company needs
This position could be a great fit for you if you have a passion for quality, excellent leadership skills and are a proven self-starter with excellent problem-solving skills along with the following:
- BS in Engineering or Life Sciences or equivalent combination of education and industry experience
- 5+ years of experience in medical device or pharmaceuticals, with specific experience in quality functions such as risk analysis, investigations and support of regulatory or client audits
- A minimum of 3 years in a Supplier Quality role
- A minimum of 2 years in a leadership/supervisory role
- Vendor management and vendor facing experience preferred.
- Comprehensive understanding of GMP regulations for medical devices, pharmaceutical products and active pharmaceuticals
- Vendor management and vendor facing experience preferred