Erick Nieves

Erick Nieves

Summary

Manager of Quality Systems with experience in all quality related fields for over twelve (12) years. Strong experience in CAPA systems and successfully implemented a CAPA certification program in Jayuya with demonstrated results reducing investigations timeline and leveling up the compliance at the same time. In charge of the training program and the validations overview. Implemented QM module in SAP for Abbott Jayuya. In charge of the documents change control system acting as a liaison between the Plant and the Division Change Control Area. A leader with a genuine quality attitude with proven ability to: promote a safe and motivating compliance environment; encouraging a culture that supports continuous improvement and employee’s participation; develop an atmosphere that promotes open communication with colleagues. Strong experience with regulatory agencies with an excellent history of compliance. Proven ability to optimize both profit and compliance standing within the portrait of the company’s mission, vision and values

Work History

Work History
Apr 2008 - Present

Quality Systems Manager

Abbott Laboratories

Responsible of the CAPA system: investigations, planned deviations, corrections, corrective actions and effectiveness checks.Develop and report quality metrics to division site.Chair the Investigation Review Board.

Responsible of the SAP system Quality Module. Responsible of the Management Review. Responsible of the training area  Responsible of the Change Control Area, including validations and procedures changes.Chair the Change Control Review Board.

Direct handling of regulatory audits as a subject matter expert and as a QA representative.

Proficient is six sigma and lean manufacturing tools.

Mar 2005 - Apr 2008

QA Operations Manager

Abbott
In charge of the Quality Operations, Quality Engineering, Incoming Quality Assurance, Batch Record Review, Corrective Action/Preventive Action, and Product Disposition processes. In charge of implementing SAP QM system on site. Sponsor, as a six sigma black belt, division six sigma projects such as cycle time reduction project. Implement a compressing QC sample reduction project with 2006 savings of 200k. Approve and perform complaint investigations when needed.
Mar 2003 - Mar 2005

Sr. Quality Engineer

Abbott
Responsible for the review and evaluation of qualification and validation protocols and reports and associated documentation. Responsible for the review and evaluation of calibrations and preventive maintenance works from a quality standpoint. Coordinate departmental efforts relative to process deviation evaluations, manufacturing and laboratory investigation, anomalous batch reporting, and product complaint investigation. Provide leadership to cross-functional teams responsible to improve product's performance in a timely manner and consistently. Lead, coordinate and perform production investigations, under minimal supervision, in order to determine root cause(s) and provide corrective (CAPA) and preventive actions in a timely manner. Oversee investigations and CAPA metrics including timeliness and compliance. Lead and perform complex investigations. Use six-sigma problem analysis tools and Kepner-Tregoe problem solving approach to identify root causes and corrective actions. Participate in the preparation and presentation of the Plant Management Review. Member of the Validation Review Board and Material Review Board. Lead the Human Error Reduction Team. Conduct internal audits as part of the internal audit team.
Apr 1997 - Mar 2003

Sr Quality Engineer

Baxter Healthcare
Responsible of the design, organization and run of validation protocols on I.V Solutions and medical devices manufacturing areas for equipment, products and/or processes validations. Member of various teams responsible of the transfers of products and/or processes Use of statistical tools such as sampling plans and capability studies as well as design of experiments in order to comply with stringent product quality standards as required by plant procedures and specifications. Conduct designs of experiments as part of protocols and factory acceptance tests (FAT). Conduct gage R&R studies to compare variability in processes and/or products. Development and update of plant SOP’s to enforce quality standards. Statistical advisory to manufacturing, labs and/or quality operational areas. Develop and offer statistical trainings to internal/external Baxters. Leading validation activities during plant’s shutdowns Assume charge of the validation department during management absence Provide support to external and internal audits. Validate software and hardware for new equipment. Generate Requirements Definitions, Functional Specifications and Live System Specifications as part of the software’s validation package. Lead to process improvement as part of validation efforts

Education

Education
1996 - Present

Bachelor Degree

University of Puerto Rico

Skills

Skills

SAP

specially the quality module

Computer literate

Excel, Word, powerpoint, Visio, Snag-it, etc.

CAPA tools

Kepner-tregoe, Contradiction Matrix, Fishbone, FMEA, etc.

Statistical packages such as Minitab and Statgraphics

Certifications

Certifications
Jun 2003 - Jun 2013

Certified Quality Engineer

ASQ
Dec 2003 - Jun 2013

Certified Quality Auditor

ASQ
Mar 2005 - Jun 2013

Certified Six Sigma Black Belt

ASQ
Oct 2006 - Jun 2013

Manager of Quality/Org. Excellence

ASQ
Jun 2010 - Jun 2013

Pharmaceutical GMP Professional

ASQ