Liaise with the reagent contract manufacturer and represent Beckman Coulter Quality in the interaction with the contract manufacturer and is responsible for the generation, analysis and reporting of quality metrics to relevant personnel and to ensure on-going improvement programs are put in place.
Lead cross functional teams providing Quality guidance and guide in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition.
Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures and perform CAPA (corrective and preventive action) activities and document in the CAPA system if required.
Review & Approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
Author relevant procedures, Review/Approve documentation (e.g. protocols, reports) ensuring compliance to applicable procedures and provide Quality expertise during the product life cycle.
Review & Approve Certificate of Analysis(COA) for the finished goods.

This position is part of the International Quality Operations located at Ernakulam, Kerala, India and will be on-site at the OEM site. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time.

You will be a part of the Quality, Regulatory and Clinical Affairs and report to the Senior Manager Quality and Regulatory Affairs, India Quality Operations responsible for Beckman Coulter Reagent Manufacturing Quality in India. If you thrive in a multifunctional role and want to work to build a world-class Quality organization read on.

In this role, you will have the opportunity to:

Define programs for manufacturing quality improvement
Execute and participate in audits(supplier audits, external audits etc)
Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the growth of and ensure alignment with BEC global policies and procedures

The essential requirements of the job include:

Minimum of 10 years experience in manufacturing quality in either medical devices or pharma industry or with background in biochemistry production in a highly regulated environment with Bachelors in Biochemistry or equivalent
Excellent organizational and communication skills and fluent in English language is required
Solid working knowledge of EU, FDA and related regulations including QSR s, (FDA 21 CFR 820), ISO 13485 or ISO 9001, IVD s,

It would be a plus if you also possess previous experience in:

Experienced in quality management methods (8D, Six Sigma, Statistical Tools, FMEA)
Experienced in working within multi-functional, multi-regional teams

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Senior Manufacturing Quality Engineer- Reagents