12262 Quality Engineer I

Job description

DUTIES AND RESPONSIBILITIES: Coordinate and plan supplier audits in conjunction with the global supplier quality, Quality Manager, procurement team, RD&E and Internal stakeholders. Conduct ISO9001 and ISO13485 (including any applicable specific requirements) audits for suppliers based on the plan / business urgency. Communication with suppliers on action plan preparation/review. Follow-up to the action plans resulting from these audits. Lead or support root cause investigation of nonconformities and develop, initiate, or implement corrective actions. Conduct periodic review and analysis supplier actions using quality tools including, but not limited to: FMEA, DFMEA, PFMEA, DQ, IQ, OQ, PQ, control plans, process verification/validation plans, equipment qualification, PDA, Cpk, SPC, statistical process control and DMAIC. Develop, implement, and ensure that the supplier conforms to customer, internal, regulatory/legal, and certifying organization requirements. Manage the documentation by creating, update, and control - Responsible for activities involved in supplier quality assurance. Prepare and provide reports, communications and/or presentations to management around the development / status of Audits. Manage and support activities related to alternate supplier approval and product specification enhancements. Lead and support quality activities including FMEA, SPC, Internal/External audit support, SCAR, and Corrective & Preventative Actions. QUALIFICATIONS: Minimum of a bachelor degree in a related discipline (Chemical engineering /Biotech engineering /production engineering/ Pharmacy etc.) and / or master degree in Chemistry/ Quality / Purchasing / Supply Chain Management. Lead Auditor Certification for ISO9001, ISO13485 and relevant standard. Must have considerable experience in conducting ISO, GMP audits for regulatory and non-regulatory industry by onsite/remote mode. Understanding of Lean, 6 sigma green belt. 3+ years of experience in Chemical or Pharmaceutical quality assurance/supplier quality assurance. Familiarity with RCA Tools, SAP, eQMS tools, Data analytics is a strong asset. Other skills required: Excellent written and oral communication Team player who is easy to work with Combination of big picture understanding and vision with outstanding attention to detail Problem solver with strong analytical skills – comfortable with both theoretical and practical issues Able to work independently and within a team. Strong ability to document work. Able to prioritize tasks effectively and to communicate roadblocks promptly to management within a fast-paced environment where project / team priorities may shift. A curious person who stays abreast of the latest techniques and technologies High degree of discretion dealing with confidential information