- Reference: GJ43550
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
As Senior Quality Engineer you will primarily be responsible for developing and maintaining all quality systems and monitoring production process for compliance to implemented process controls. Under minimal direction, manage Quality projects that may cover multiple sites.
- Interfaces directly and regularly with customers; internal and external. 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.
- Compliance with all Regulatory Standards.
- Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer tools & templates were available.
- 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
- Liaise with Engineering department 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
- 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
- Maintenance of customer concerns handling system in a timely manner including;
- Returned product analysis
- Organisation, filing and reporting of customer concerns
- Ensure the requirements of the Electronic Documentation Management system are understood and implemented at all levels of the organization
- Accountable to monitor manufacturing activities, measure significant process characteristics and analyse variation in order to detect and reduce waste
- Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements
- 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, Experience and Qualifications:
- 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/company please contact Christopher O’Toole on 091-706713 or email email@example.com
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