Senior Quality Assurance Engineer - Parkmore Galway

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

JOB SUMMARY

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 high-impact Quality projects that may cover multiple sites. Duties will involve coordination, and scheduling of program or project activities from concept though to commercialization.  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.

POSITION REQUIREMENTS

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 organization.

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)
• Strong proficiency in Failure Modes and Effects Analysis (FMEA) for both design and process risk assessments.
• Demonstrated ability to lead and close Corrective and Preventive Actions (CAPA), ensuring timely resolution and compliance with regulatory requirements.
• Experienced in root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagram, Fault Tree Analysis) to identify and eliminate systemic issues.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

• Demonstrated experience in leading or supporting cross-functional projects, including new product introduction (NPI) and sustaining engineering activities.
• Engineering, Science or Project Management Bachelor’s Degree preferably with Quality Engineering included.
• Strong knowledge of regulatory standards: ISO 13485, FDA QSR, EU MDR, and applicable international requirements.
• Qualified systems lead auditor
• Program or project management certification or significant experience in managing quality deliverables within complex project
• Minimum 5+ years of experience in the medical device industry, with a proven track record in quality engineering and project support.

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U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.