12262 Quality Engineer I

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