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Quality Manager (Operations)

Title : Quality Manager (Operations) profile
Sector : Engineering & Technical
Scientific & Laboratory
Location : Galway
Reference : CW121822
Contact : Tom Devaney
Office : Galway
Tel : 00353-91-758771
Email : tdevaney@careerwise.ie

Job Description

A Quality Manager in Operations is required by CareerWise Recruitment for our Galway based client. Main task is to proactively protect the customer through ensuring that all products are manufactured to the highest standards and under the highest GMP conditions.Please contact Tom Devaney for more information.

Role of this position

  • Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.
  • Manage all quality related activities for finished device manufacturing and participate in Site & Corporate initiatives.
  • Understands and complies with all regulations governing the quality system.
  • Ensures the quality operations team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
  • Leads and demonstrates expertise in the areas of QSR and ISO standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.
  • Ensure compliance to the quality management system in all activities.
  • To support audits from external regulatory agencies (FDA, BSi) and customers and to lead preparation activities in advance of such audits.
  • Ensure all customer queries and concerns are professionally addressed in a timely manner.
  • Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures.
  • Develops and manages a high performance quality engineering team. Creates a strong team working environment with focus on customer needs, compliance, product quality, and risk mitigation.
  • Delivers process improvements that reduce cost or improve the quality of the product.
  • Develop strong links with customer organisations.
  • Participate in new product introductions to ensure quality is built into all products early in their life cycle.
  • Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.
  • Drives robust and effective corrective and preventive action programs through the CAPA system.
  • Provides best in class problem solving tools.
  • Facilitates root cause investigations for online QA issues.
  • Expected to play active role in the execution of the site Quality Excellence Program particularly those projects identified to drive quality system effectiveness.
  • Works cross-functionally to deliver on the site strategic targets and objectives.
  • Ensures staff are trained to perform effectively their work and their training is documented.

JOB REQUIREMENTS

  • A Level 8 Degree inf Engineering, Sciences or equivalent qualification.
  • Proven track record in a similar role with a minimum of 5-8 years experience at that level within the Medical Device or related industry
  • Excellent hands-on technical skills.
  • Good coaching/mentoring skills.
  • Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
  • Experience in people management and development.
  • Strong team building skills with proven abilities in decision making and sound personal judgment
  • Good organization, supervisory and investigation skills are required.
  • Proven ability to influence

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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Careerwise Recruitment



Quality Manager (Operations)

Title : Quality Manager (Operations) profile
Sector : Engineering & Technical
Scientific & Laboratory
Location : Galway
Reference : CW121822
Contact : Tom Devaney
Office : Galway
Tel : 00353-91-758771
Email : tdevaney@careerwise.ie

Job Description

A Quality Manager in Operations is required by CareerWise Recruitment for our Galway based client. Main task is to proactively protect the customer through ensuring that all products are manufactured to the highest standards and under the highest GMP conditions.Please contact Tom Devaney for more information.

Role of this position

  • Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.
  • Manage all quality related activities for finished device manufacturing and participate in Site & Corporate initiatives.
  • Understands and complies with all regulations governing the quality system.
  • Ensures the quality operations team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
  • Leads and demonstrates expertise in the areas of QSR and ISO standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.
  • Ensure compliance to the quality management system in all activities.
  • To support audits from external regulatory agencies (FDA, BSi) and customers and to lead preparation activities in advance of such audits.
  • Ensure all customer queries and concerns are professionally addressed in a timely manner.
  • Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures.
  • Develops and manages a high performance quality engineering team. Creates a strong team working environment with focus on customer needs, compliance, product quality, and risk mitigation.
  • Delivers process improvements that reduce cost or improve the quality of the product.
  • Develop strong links with customer organisations.
  • Participate in new product introductions to ensure quality is built into all products early in their life cycle.
  • Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.
  • Drives robust and effective corrective and preventive action programs through the CAPA system.
  • Provides best in class problem solving tools.
  • Facilitates root cause investigations for online QA issues.
  • Expected to play active role in the execution of the site Quality Excellence Program particularly those projects identified to drive quality system effectiveness.
  • Works cross-functionally to deliver on the site strategic targets and objectives.
  • Ensures staff are trained to perform effectively their work and their training is documented.

JOB REQUIREMENTS

  • A Level 8 Degree inf Engineering, Sciences or equivalent qualification.
  • Proven track record in a similar role with a minimum of 5-8 years experience at that level within the Medical Device or related industry
  • Excellent hands-on technical skills.
  • Good coaching/mentoring skills.
  • Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
  • Experience in people management and development.
  • Strong team building skills with proven abilities in decision making and sound personal judgment
  • Good organization, supervisory and investigation skills are required.
  • Proven ability to influence

Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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