- Actively participate in product development and transfer activities with cross-functional teams, as well as product field and internal quality initiatives to ensure product and process conformance to FDA and ISO 13485 standards.
- Serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability.
- Participate in product quality investigations and responsible for identifying and championing sustainable supplier quality improvements.
- Facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools.
- Responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products.
- Bachelor's degree in an engineering or science discipline with 5-8+ years' experience in quality assurance field in a regulated environment.
- Direct experience working in in-vitro diagnostic manufacturing is preferred.
- Quality Certification preferred (e.g., CQE)
- Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, and ASTM E2500-07 Verification Guideline)
- Practical experience in design controls, risk management, validation, change control, and supplier quality
- Experience with CAPA and failure investigation tools and techniques
- Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
- Highly effective communication, facilitation, coaching, and negotiation skills
- Adaptable to fast-paced environment with shifting demands
- Demonstrated ability to accomplish goals while working across departments is required
Sthree US is acting as an Employment Agency in relation to this vacancy.