- Reference: CJ44657
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
Develops, establishes and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction. To ensure the implementation of all Quality Systems across the site.
- Management, coordination and development of the following processes and groups working within the function – Management Review, CAPA, Internal Audit, Management Review, Strategic Quality initiatives & Site wide CAPA Projects, Process and Software Validation, Documentation Control and Operations Quality.
- Compliance of Site Quality System & Validation activities to Corporate requirements and FDA, EU, MDD, TGA, PAL & CMDR regulations for Medical Devices.
- Provide leadership role on championing best Quality practices and ensure all Corporate Quality Objectives applicable to function are met.
- Participate as a key member of the departmental staff team contributing to the overall business quality strategy.
- Establish cross-functional team relationships & apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving technical & quality issues.
- Provide significant guidance and approval regarding technical strategies and approaches.
- Project manage and schedule key projects and initiatives insuring timely execution and goal achievement.
- Be recognized as champion of behavioural/GMP and cultural initiatives with strong quality related decision making skills demonstrated.
- Support to and facilitation of external audits.
- Influence, define and integrate with functional, departmental, Corporate and divisional policies & procedures through involvement with cross-functional initiatives.
- Develop and control department budgets and determine appropriate staff levels, schedules and resources. Ensure compliance to financial requirements
- Complete Quality commitments as per site Quality Plan for each year and in line with corporate directives and quality strategies.
- Develop staff on quality initiatives and assist in the understanding and rollout of quality initiatives across the department/site.
- Provide guidance and mentoring to staff, assist team members in developing career goals, motivate individuals to achieve results, and recruit and maintain high quality staff.
Experience & Qualifications:
- Requires a minimum level 8 relevant Engineering / Science degree
- Ideally 8 years’ experience within the medical device or pharmaceutical manufacturing industry, with at least 4 years’ experience in a leadership role.
- Experience/training in problem solving and process improvement methodologies.
- Excellent interpersonal and communication skills with good leadership abilities.
- Ability to work as part of a team and meet targets/goals efficiently.
- Excellent analytical and problem solving skills.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.
For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!