C. R. Bard, Inc. Sr. Quality Engineer in Reynosa, Mexico
2.1 Responsible to assist the Quality Manager and/or Quality Engineering Manager on the department activities such as yearly goals, objectives, department budget, identification of the areas of opportunity, implementation of the Quality Systems and maintain the facility within GMP compliance and FDA regulations. Develop and update the inspection procedures and methods used for product quality evaluation. Responsible to supervise and develop the Associate Quality Engineer and Technician. Lead the product transfer activities and comply with the due dates. Responsible for the Quality and compliance of the new transfer. Develop and execute the product and process validation, conduct customer complaint evaluation and participate with the internal audits as needed.
The regular activities of the Sr. QAEngineer are:
Solve the manufacturing and quality problems, support the manufacturing operation and responsible for quality improvement. Demonstrate ability to isolate and define problems.
- Implement the appropriate and efficient corrective actions to avoid problems, responsible of process optimization, scrap reduction and cost reduction.
- Provides support during product and process validations by guiding the team during IQ, QC & PQ stages of the validation process.
- Responsible for product and process validations within the facility and external suppliers (I/OQ & PQ) that include testing equipment and tooling.
Interact with corporate and divisional personnel to clarify specification, product design changes, quality issues and technology transfers.
Lead the product and process transfer; responsible to met the transfer due date, smooth transfer without major quality issues.
Responsible to develop and maintain the quality documentation and monitor the manufacturing documentation according to regular practices
Responsible to supervise the Associate Quality Engineers and Quality Technicians and evaluate their work performance.
Support the Quality Engineer Manager and Quality Manager in the budget activities and capable to create developmental plans for his subordinates.
Leads teams during the investigation of root cause, quality problems and complaints using statistical techniques (DOE, ANOVA, Regression, Analysis, etc.).
Improve manufacturing, inspection and test documentation to ensure that customer requirements are met.
Ensure GMP regulations; ISO and Corporate Guidelines are followed.
Responsible for technical supervising in the in process inspector of the assigned lines.
Responsible to identify areas of opportunities (MRR) for the areas by praetors and improvement plans.
- Knowledge in GMP, ISO CE mark compliance and FDA regulations, experience with medical device manufacturing process.
Bachelor Degree in Engineering Master degree desired.
Industry Title/Category: Medical Industry
Career Level: experienced
Close Date: 7/31/2016
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.