- Reference: CJ43735
- Job Type: Permanent
- Location: Cork, Cork City, Munster
- Category: Engineering, Technical & Manufacturing
Position Reports To: VP Quality & Regulatory for C&V Product Category
The Senior Quality Engineer will primarily be responsible for developing and maintaining all quality systems and monitoring production process for compliance to implemented process controls. Under minimal direction, manages Quality projects that may cover multiple sites. Duties will involve coordination, and scheduling of program or project activities. Assignments are broad in scope with the opportunity for the use of independent judgment. Essential Quality engineering skills are required.
Essential Job Duties And Responsibilities:
Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job related tasks which may not be specific to this position profile.
Interfaces directly and regularly with customers (internal and external) staff. Often is included in critical business discussions with customers to bring deep insight to a problem or opportunity and establish a high level of credibility for Integer through demonstrated program management knowledge and expertise.
Proactively manage the risk associated with projects so that Integer’s and the customer’s business objectives are achieved. Minimize the uncertainties associated with projects relative to scope changes, customer expectations, business issues and other intangibles to enable successful completion of projects.
Involve and coordinate the input of all key functional groups and contributors to the proposed work plan.
Follows and develops Quality and Regulatory requirements including Integer’s policies, procedures, and appropriate regulatory requirements and have the standard Quality engineering skill set as outlined below.
Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer tools & templates were available.
As outlined above must have standard Quality engineering skills as outlined below:
1. Compliance with all Regulatory Standards, this includes:
- Completion of internal audits to:
- ISO 13485
- FDA QSR
- ISO 14000
- Participation in Corporate auditing programs
- Ensuring continued compliance with DMR
2. Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
- Participation in validation protocol development
- Overseeing completion of validation or validation samples
- Supporting the engineering function to ensure compliance to related element of quality system
3. Liase with engineering departments on new product development projects to ensure;
- All quality control requirements for non standard product are clearly understood
- All product samples for new product development qualification are inspected
- Relevant process controls are documented and transferred to production and suitably implemented with necessary training
4. Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
- Trend analysis of data from the controls
- Potential improvements for review with engineering based on the trends
- Areas for Improvement to senior management
- Review and propose changes to sampling plans based on trend analysis and changes to the system
5. Maintenance of customer concerns handling system in a timely manner including
- Returned product analysis
- Organisation, filing and reporting of customer concerns
6. Ensure the requirements of the Electronic Documentation Management system are understood and implemented at all levels of the organisation
7. Accountable to monitor manufacturing activities, measure significant process characteristics and analyse variation in order to detect and reduce waste
8. Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements
9. Play a leadership role in encouraging the Company to achieve world class standards, above all by setting your own high professional standards as an example.
Skills And Knowledge:
- Ability to communicate and work with people inside and outside the department.
- Excellent communicator: verbal, written and presentation skills.
- Ability to train and lead assigned employees.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods.
- Rigorous attention to detail.
- Ability to use Microsoft Office Suite (Excel, Project, Word, PowerPoint at a minimum) and ability to use / learn Oracle as the company ERP system (preferably Oracle)
Minimum Education And Experience Requirements:
- Demonstrate leadership in project management
- Engineering or science Degree preferably with Quality Engineering included
- Qualified systems lead auditor
- Program Management certification or number of years experience
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
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