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.

Originally posted on Himalayas