Quality Assurance Director

Galway  ‐ Onsite
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Keywords

Description

I have an immediate opening for a Director of Quality Assurance Europe with a leading multi national medical device company based in Galway.

This is an excellent opportunity to join a highly respected company in a Director level position. This company has an excellent reputation within the medical device industry and really looks after and values their staff.

Responsibilities:
- Key member of Senior Leadership Team that manages, develops and drives MEO to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.
- Sets strategy to enhance and maintain MEO's Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, markets served e.g. US, Canadian, EMEA, Asia, CSR (Customer Specific Requirements).
- Assigned Quality System Management Representative for the company, primary regulatory agency and customer contact on all quality related queries for the region e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.
- Select, provide guidance, direction and supervision to Quality Assurance Personnel. Identify and make provision for required training to ensure proper and efficient completion of all quality assignments.
- Develop and manage quality departmental budgets.
- Promote, support the Business Excellence Program; lead by example; Partner with function leaders to ensure that this program and the organisation values are at the forefront of decision making and action.
- Partner with other company locations globally in the development of partnership systems for standard business, quality processes.
Note: The above list is not intended to be exhaustive, but highlights the key responsibilities at this time

Qualifications
- Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable.
- Eligible for inclusion on the site manufacturing licence as Qualified Person, desirable.
- 10 Years (+) work related experience of which at least four years' experience is in the medical device manufacturing industry in a similar role, coupled with a proven track record in leadership and development of a large, international team, in multiple regions.
- Proven track record in leading organisations through external inspections / audits (e.g. FDA, Notified Bodies, Competent Authorities, Customers), essential.
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), and JPAL/JGMP
- PC skills including standard offices packages as well as ability to understand and learn customised computer software programs.

Competencies
- Strong Leadership ability, with presence and the ability to influence at all levels within the organisation.
- Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external.
- Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively. Attention to detail without losing site of the big picture.
- Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process.
- Strong project management skills, including the ability to prioritise, balance, and manage multiple efforts with strong results/goal orientation.
- Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
- Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.
- Demonstrate organisational values (Customer First, Achieving Excellence, Developing People, Flexibility and Integrity) in carrying out of all assigned responsibilities/tasks.

If you feel you are a good fit for this role and are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for further information.
Start date
08/2014
From
Real Staffing
Published at
12.07.2014
Project ID:
740853
Contract type
Permanent
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