- Reference: GJ42984
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
The QARA Manager will report to the Director of Operations. This person’s main responsibilities will be to ensure the effective development and management of the Quality System and to achieving annual business objectives.
- Developing and driving quality strategy and setting quality objectives for the business.
- Direct the activities of the Quality Team. Ensure compliance with all appropriate regulations and standards, including FDA (QSR) and ISO 13485.
- Management of the customer experience from a quality perspective.
- Oversee all external regulatory inspections. Fulfil the role of management representative.
- Attract, retain and proactively develop a pipeline of key talent through coaching, training, experience development and internal/external recruitment.
- Lead the integration of the quality system with the business management system (SAP). Ensure that effective and efficient “best in class” electronic systems are used as part of the Quality Management System.
- Develop a culture of continuous improvement. Champion the implementation of performance improvement methodologies based on lean and six sigma concepts.
- Keep your skills current and be conversant with the latest developments in technologies and materials which are relevant to the Company’s business.
- Perform a leading role in developing and achieving the strategic business plan.
- To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agree with Management prior to any assignment.
- To meet and/or exceed the Milestones agreed with the Company.
Skills, Experience and Qualifications:
- Bachelors in a scientific discipline – up to 7-10 years’ experience in the medical device manufacturing industry; strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
- Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC) and other national and international regulations and standards.
- Have successfully lead preparations for FDA and EU Notified Body audits.
- Experience building up a quality culture and quality management capabilities.
- Have the ability to demonstrate confidence during difficult decision-making and influence internal and external business partners to ensure acceptable quality outcomes.
- Must have previous experience in implementing lean and six sigma concepts.
- Experience of electronic quality systems design and integration an advantage.
For a confidential discussion and more information on the role/company please contact Christopher O’Toole on 091-706719 or email firstname.lastname@example.org
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