Senior Supplier Quality Engineer
A growing biotechnology / life sciences company has an opening for a Senior Supplier Quality Engineer. Our client is a leading provider of products and services to accelerate development of viro-immuno-oncology drugs.
Connect with us to learn more about this great opportunity.
In this role you will:
- Lead supplier qualification and monitoring tasks for commercial and new business development product lines
- 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
- Implement supplier corrective actions
- Perform external vendor audits
- Maintain approved supplier lists
- Review and approve new documents and change orders
- Demonstrate continuous improvement
- Successfully attain budget/ business objectives
- Remain current w/ regulatory and industry requirement relevant to the medical device industry
- Medical and Dental Insurance
- HSA / Flex Spending
- 401K Matching
- Short Term / Long Term Disability
- Life Insurance
- PTO/ Holiday Pay
- Tuition Reimbursement
- BS in Scientific Discipline or Engineering - Preferred!
- or equivalent combination of education and experience in a medical device or pharmaceutical industry
- ASQ Quality certification - CQA or CQE - Preferred!
- 5+ years of experience in medical device or pharmaceuticals, including quality functions-risk analysis, investigations, and support of regulatory or client audits.
- Min of 3 years in a Supplier Quality role
- Previous experience in a vendor management and vendor facing experience – Preferred!
- In depth knowledge/ experience working w/ the following regulations - 21 CFR 820 (FDA Quality System Regulation) and 21 CFR 210-211 (FDA Good Manufacturing Practice)
- Previous experience w/ the following standards - EN ISO 13485, ICH Q7, GMP Guide for Active Pharmaceutical Ingredients, ISO14971, Risk Management, and European Medical Device Directive
- Collaborative Team Player
- Previous experience performing Root Cause Analysis
- Skills to be successful – self-starter, organized, ability to prioritize, problem-solving skills, effective technical writing, and oral communication skills
Keywords: chemistry, engineering, quality, medical device, pharmaceutical, FDA, GMP, pharma, cell culture, biopharmaceutical, supplier
"By applying to this position, you are confirming that you understand the requirements needed for this position, and further confirm that you possess the necessary skills and requirements, as outlined above".