Find Regulatory affairs Jobs in Fermoy, C

Quality Engineer
Sanmina Corporation —Fermoy, County Cork
- Microsoft Word
- Microsoft Excel
- Customer service

Check out these similar jobs

Based on your search for regulatory affairs jobs.

IT Support Engineer - Helpdesk
PFH Technology Group —Little Island, County Cork
Updating helpdesk documentation so that support information is available and current for. Reassign and schedule support calls with the extended field and onsite…
Quick apply
Biotech Utilities Operator
Controlled environment solutions —Cork, County Cork
Carry out daily sampling and testing duties as assigned on the above listed systems to ensure equipment and systems are in good operating conditions and they…
Quick apply

I want to receive the latest job alerts for regulatory affairs in fermoy, c

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs jobs near fermoy, c

Quality Engineer jobs in County Cork

Validation Engineer jobs in Cork, County Cork

Engineer jobs in County Sligo

Quality Engineer jobs in Castlebar, County Mayo

Quality Engineer jobs in Galway, County Galway

Quality Engineer jobs in County Laois

Quality Engineer

Sanmina Corporation -
Fermoy, County Cork

Apply Now

Job details

Qualifications

Microsoft Word
Microsoft Excel
Customer service
Engineering
Six Sigma
Quality assurance
Data collection
Manufacturing

Full job description

DEPARTMENT: Quality Department

REPORTING TO: Quality Engineering Lead

About Sanmina Fermoy

Our Fermoy, Ireland, facility is FDA registered and certified to ISO ISO13485:2016 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. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.

We hire people with a range of skills, experience, and backgrounds to fulfill roles in careers such as engineering, quality and manufacturing to name just a few.

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

Core Competencies:

Sound understanding and utilization of Problem Solving Techniques.
Good Communications and influencing skills.

Apply Now

Refine Your Search

regulatory affairs jobs in fermoy, c

Quality Engineer

Check out these similar jobs

I want to receive the latest job alerts for regulatory affairs in fermoy, c

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected