As a
medical device company,
we help people in a truly tangible way. We are one of the most modern electronics factories, which gives us the opportunity to develop and build a career working with the latest technologies. The knowledge and skills you'll gain here are unique, and you'll find new challenges and endless opportunities along the way.
Our Fermoy, Ireland, facility is
FDA
registered and certified to
ISO
for the manufacture of
high-quality PCBAs
, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoy's core specialization is manufacturing automation. The facility has a track record of
30 years of outstanding operational performance
and customer service, backed by a highly experienced workforce.
OBJECTIVES OF POSITION:
* Primary objective is to ensure customer satisfaction by
monitoring, controlling and improving
all related customer processes.
* Principal customer interface for
Quality metrics
and improvement initiatives.
* Identifies, plans, and organizes regulatory affairs for ensuring compliance with the FDA's
Quality System Regulations, ISO 9001, ISO 13485, ISO 14001, PDML Japan Quality Management
, as well as any international standards relevant to customer products for Sanmina manufacturing facility.
RESPONSIBILITIES:
* Management of closed loop customer complaints and improvement processes.
* Generation and Review and review of Quality Metrics System.
* Overall responsibility for
DMR/DHR and Technical Files.
* Data collection, analyzing and reporting.
* Pareto and trend analysis.
* Initiate and drive Continuous Improvement programs.
* NPI Approval including First Article Inspections and Reporting
.
* CAPA, NCM and RMA
analysis and Improvement.
* QSR Validation protocols and report (IQ, OQ & PQ).
* Conducting Audits to ensure conformance and effectiveness of the
Quality System.
* Assure ongoing compliance with quality and industry regulatory requirements.
* Ensure compliance with Health & Safety Legislation and Regulations.
MEASUREMENTS:
* Yields at Key Process Steps.
* Customer Satisfaction Index, (CCN, CSO etc).
* Customer Return % and Cost (RMA).
* Scrap %.
* Outgoing Inspection DPM & Customer Incoming Quality Levels.
PERSONNEL SPECIFICATIONS
* Minimum
NFQ Level 7 Degree/ Diploma in Science or Engineering,
or a lesser qualification with sufficient job related experience.
* At least
2-3 years Quality Assurance / Regulatory affairs
experience. In a similar Quality Engineering role in the electronics manufacturing industry is preferred.
* Proficient in the use of Microsoft Word, Power-point and Excel.
* Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
* Ability to write standard operating procedures, training documents, and regulatory responses.
* Experience in working within a
Class 3 Medical Device Manufacturing Environment
is preferred.
* Six sigma Green or Black Belt Certified is preferred.
* Experience in New Product Introduction Processes is preferred