Principal Global Process Owner - Quality Improvement

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: The Principal Global Process Owner – Quality, Improvement is considered successful if you: 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 excellent communication, facilitation, and leadership skills, with an ability to influence and drive change across diverse teams and cultures. Specialized Skills: You have a strong desire to help others You demonstrate a continuous improvement mindset and a strong drive to overcome challenges in achieving goals and delivering results You will need to be able to query systems, conduct data analysis and communicate results in a timely manner that facilitates business decision making You have expertise in process mapping, analytics and continuous-improvement You are a proven change leader having achieved stakeholder alignment in matrixed and cross-functional environments You possess excellent communication, ability to influence and negotiation capabilities Your business acumen is excellent and includes an understanding of how the quality process impacts financials and operations You have the ability to manage complex projects including the coordination of global rollouts with multiple workstreams You are familiar with governance, compliance and industry specific regulations You are proficient in leveraging technology solutions to achieve the best solutions. This role is part of the Global Quality Systems team for a company based in the United States with sites globally. The role is remote; however, the person must have the ability to flex their schedule in line with business needs as required. U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.