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Vacancy Details

Engineering & Technical

QA Manufacturing Team Lead - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 3/08/2016
Job Reference: 84390

Job Description

QA Manufacturing Team Lead

Our client a leading medical device manufacturing company located in Cork, requires an experienced QA Team Lead for a permanent job. The QA Manufacturing Team Lead will lead from a Quality perspective the production activity on site

Key Responsibilities:
? Manage the activities of a defined team of QA personnel. Management responsibilities to include day to day work allocation and prioritisation, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties
? Actively support all defined Plant goals and objectives.
? Co-ordinate all Six Sigma activities across the site.
? Lead QA Manufacturing on existing products & new product development/transfers.
? Responsible for recruitment, development and training of all QA Manufacturing Support personnel
? Administration/implementation of Traceability for C of C documentation, DHR systems
? Establish and administer Operator Inspection programme and provide initial training certification as required on an ongoing basis to support objectives
? Maintain manufacturing audit inspection and activity
? Implement and maintain CSOPs to ensure total compliance in areas of responsibility
? Resolve problems & eliminate constraints to ensure project targets are met.
? Ensure that all relevant Quality Data is recorded, reported and actioned in an efficient manner. (Scrap, MRR etc.)
? Represent QA manufacturing at monthly CAPA meeting.
? Be responsible for the release of product to the sterilization contractor for the plant.
? Ensure that all DHRs are complete and accurate via appropriate system controls
? Identify and carry out required Quality inspection training
? Ensure resources are available for complaint investigation when required.
? Ensure the plant complies with GMP, ISO and QSR requirements.
? Manage repack from a QA perspective
? Ensure effective and timely communications both oral and written (weekly/monthly written reports, Project updates, daily / weekly direction to Quality personnel)
? Support preparation of and maintenance of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), Raw Material Specifications (RMS) etc.
? Represent Quality in Planning/Customer Service meetings to support timely delivery of service to ensure continuous supply of good product to distribution.
? Co-ordinate the activities of the QA Manufacturing Support group in managing Operator Certification.
? Ensure effective and timely closure on all Corrective Action Requests, Failure Investigation Reports and Close Call Investigation.
? Maintains standards of housekeeping & GMP requirements
? Ensure QA Manufacturing personnel maintain a systematic control of documents.
? Represent the Quality function as required by management
? Ensure that all Health, Safety and Environmental requirements are fulfilled.
? Continuous Improvement Focus
? Continuous Improvement Focus

Qualifications & Experience
? A degree level or similar qualification in mechanical or industrial engineering.
? Minimum 3 years in Medical Device Manufacturing in a people management role.
? Proven ability to successfully manage QA systems in the Medical Device Industry. Proven knowledge and ability regarding product verification and process validations.
? Proven knowledge of FDA and MDD GMP requirements regarding medical Devices.
? Proven experience and training n Light Mechanical Engineering processes ? machining ? casting ? forging etc.

For further information on this QA Manufacturing Team Lead role in Cork please contact Cliona O?Malley on 091730022 / cliona@hero.ie
Check out all our open jobs on our HERO Recruitment website ? www.hero.ie

Please Note: HERO Recruitment will not forward your details to any company without your prior approval


Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
More

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
More

Clients we are proud to work with

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