Principal Global Process Owner - Quality Improvement

integer; Ireland; On-site; EUR 120,000 - 170,000; Full time

Job summary

Integer seeks a Principal Global Process Owner in Global Quality to drive the IQMS across multiple sites. You will define global standards, govern subprocess execution, and enable digital workflows with IT collaboration to ensure sustained performance and audit readiness.

You will lead a community of users, manage corrective actions from audits, and champion best practices to reduce variability and improve efficiency across sites.

Qualifications

• 8-15+ years of manufacturing experience, preferably medical devices.
• Proven track record leading enterprise-wide transformations.
• Bachelor's degree recommended; master's/doctorate advantageous; Lean Six Sigma desirable.

Responsibilities

• Provide end-to-end Process Leadership for the assigned subprocess.
• Serve as global design authority for standard definition and change control.
• Monitor process performance across sites with KPIs; trigger corrective actions.
• Lead cross-functional project teams to milestones and objectives.
• Ensure regulatory compliance (FDA QSR, EU MDR) and ISO 13485 alignment.
• Lead periodic reviews of procedures and training materials.
• Own digital workflows and system capabilities; partner with IT for enhancements.

Skills

Subject matter expert

Enterprise-wide transformations

Change management

Cross-functional leadership

Education

Bachelor's degree in engineering, life sciences or related field

Master's degree or Doctorate desired

Lean Six Sigma certification desirable

Tools

Quality management systems

Root cause analysis

Job description

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

Role Summary:

The Global Quality Systems team is the single end-to-end owner for the Integer Quality Management System (IQMS) ensuring consistent application of standards, regulatory compliance and measurable business impact across all sites. The Principal Global Process Owner - Global Quality, Improvement role is part of the Global Quality Systems team and is the single end-to-end owner for the assigned IQMS sub-process. In this role, you are accountable for defining global standards, governing process execution, enabling digital workflows and delivering tools / process that allow for sustained process performance across all sites. You hold decision authority for global process standards, procedural changes and system-level corrective actions within your assigned subprocess. You will lead an empowered user community, establish clear decision rights, ensure regulatory compliance, audit readiness, and will make measurable business impact.

Key Responsibilities:

• Providing end-to-end Process Leadership
• You are recognized as a subject matter expert for your assigned sub-process(es) and serve as a global design authority responsible for standard definition, control and change management.
• You will monitor process performance across all sites using Key Performance Indicators (KPIs) with authority to trigger corrective actions, standard work updates, or targeted interventions where performance or compliance gaps exist.
• You will lead cross-functional projects teams to achieve milestones and objectives
• You will ensure processes are aligned with regulatory requirements (such as US FDA 21 CFR, EU MDR) international standards (such as ISO 13485), customer expectations and internal quality standards.
• You will lead periodic reviews and updates of procedures and training materials.
• You act as the business owner for digital workflows and system capabilities supporting your assigned subprocess(es) partnering with IT to prioritize enhancements and ensure data integrity.

Engaging users and Stakeholders

• You will lead the community of users and stakeholders to drive adoption of standard processes and best practices.
• You will operate through coaching, workshops and targeted interventions.
• You will facilitate cross-functional collaboration to resolve systemic issues and enhance product quality.
• You will be a key opinion leader to set goals and objectives that align to the business

Deliver timely solutions and audit excellence

• You will take an ownership role in systemic corrective actions arising from audits, ensuring consistent root cause identification and sustainable fixes across all impacted sites.
• You will champion best practices across sites to reduce variability and improve efficiency.
• You will support Integer sites during audits including customer and regulatory audits as necessary.

How you will be measured:

• Adhere to all Integer Values: Customer Perspective, Accountability, Agility, Candor, Inclusion and One Team.
• Are an active supporter of the Integer Environmental, Health, Safety & Security programs
• Reduce process variability
• Reduce site-to-site deviations
• Improve audit outcomes related to assigned subprocesses
• Deliver quantifiable cost-of-quality and efficiency improvements linked to targeted process changes
• Improve data continuity
• Nurture an engaged community tied to your sub-process
• Meet your defined Goals and Objectives specifying key projects and expected milestones to achieve

What sets you apart:

• Education and Experience: You are technically renowned as a subject matter expert, a recognition typically earned through 8-15+ years of experience in a manufacturing environment, preferably in a medical devices setting.
• You have a proven track record leading enterprise-wide transformations.
• A bachelor's degree in engineering, life sciences or related technical field is highly recommended. Preferably, you also have a master's degree or a Doctorate. In addition, a Lean Six Sigma certification or equivalent is desirable.

Specialized Knowledge:

• You will have leveraged relevant Domestic and International Regulations and Industry Standards (e.g. FDA QSR, EU MDR, ISO 13485, etc.)
• You will have a strong knowledge of Quality Management System processes.
• You will have experience with global quality systems and multi-site operations.
• You will have proficiency in root cause analysis methodologies and quality tools.
• You will have excell