Director Quality Operations Jobs in Rochester, IN

Build More Than a Job—Build a Career at SpiTrex CTE

At SpiTrex CTE, we invest in our people. You’ll find opportunities to grow, real flexibility, and a culture that values balance, development, and teamwork.

Why join CTE?

• Career Growth: Ongoing training and development through Bamboo Path Track & Litmos
• Flexibility: Flextime options that support real life
• Culture: Team events, Donut Fridays, food trucks, and more
• Rewards: Referral bonuses, quarterly bonuses, and a 401(k) with 50% company match (up to 10%)
• Benefits: No-cost vision, life, and short-term disability; dental & medical with HSA or PPO options

Ready to grow with a company that values you? Join SpiTrex CTE.

This position would be able to work remotely.
1st Shift: Monday to Thursday, 6:30AM - 3:30PM; Friday, 6:30AM - 10:30AM

Essential Functions:

• 
  Lead and maintain the organization's supplier quality management program in alignment with applicable quality system and regulatory requirements.
• 
  Develop, implement, and maintain processes for supplier qualification, approval, monitoring, and ongoing performance management.
• 
  Conduct supplier risk assessments and develop appropriate mitigation strategies based on supplier capability, quality history, criticality, and business risk.
• 
  Lead supplier qualification, onboarding, evaluation, and approval activities in partnership with Procurement and internal stakeholders.
• 
  Plan and conduct supplier quality audits and assessments to evaluate compliance with applicable quality standards, specifications, procedures, and contractual requirements.
• 
  Document supplier audit findings and work with suppliers and internal stakeholders to ensure timely and effective resolution.
• 
  Manage supplier corrective action requests (SCARs), including investigation, root cause analysis, corrective action development, implementation, and verification of effectiveness.
• 
  Investigate supplier-related quality concerns and coordinate appropriate containment, disposition, and corrective action activities.
• 
  Provide technical support for supplier-related nonconformances, defects, and quality issues, including root cause and problem-solving activities.
• 
  Review and assess supplier change notifications to determine potential impacts to product quality, manufacturing processes, regulatory requirements, and business operations.
• 
  Collaborate with internal Quality and Engineering teams to determine appropriate validation, qualification, inspection, or other actions associated with supplier changes.
• 
  Develop and maintain supplier scorecards and performance metrics, including quality, delivery, responsiveness, corrective action, and other applicable measures.
• 
  Analyze supplier quality data and trends to identify recurring issues, emerging risks, and opportunities for improvement.
• 
  Partner with Procurement on supplier selection, qualification, performance evaluations, and supplier development activities.
• 
  Support incoming quality inspection and receiving functions by providing technical guidance and problem-solving assistance for supplier-related issues.
• 
  Participate in cross-functional investigations, CAPA activities, continuous improvement initiatives, and quality improvement projects.
• 
  Prepare supplier quality reports, metrics, and trend analyses for leadership and management review.
• 
  Establish and maintain effective working relationships with suppliers and internal stakeholders to promote accountability, communication, and continuous improvement.
• 
  Provide guidance and technical support to internal teams regarding supplier quality requirements and expectations.
• 
  Support special projects, strategic quality initiatives, and other duties as assigned
• Conform to ISO13485, 21 CFR Part 820, and medical device industry requirements
• Other work-related tasks as assigned
  

Competency:

• Strong knowledge of supplier quality management principles and quality engineering practices.
• Strong analytical and problem-solving skills with the ability to identify root causes and develop sustainable solutions.
• Ability to interpret engineering drawings, specifications, inspection requirements, and other technical documentation.
• Ability to effectively assess supplier capability, process controls, and quality risks.
• Strong project management and organizational skills.
• Ability to influence and collaborate across functional teams without direct authority.
• Strong interpersonal and relationship-building skills with both internal and external stakeholders.
• Ability to communicate complex technical and quality requirements clearly and effectively.
• Demonstrated attention to detail and commitment to product quality and customer requirements.
• Proficiency with Microsoft Office applications and quality management systems.
  

Educational Requirements: 

A.S. in Engineering field preferred or minimum of 2 years in Quality Engineering role

Experience:

Medical Device manufacturing preferred

3 – 5 years of experience in Quality setting preferred

Benefits Include:

• Medical, Vision and Dental Insurance
  
• Short-Term Disability
  
• Life Insurance
  
• 401(k) - 50% company match (up to 10% contribution)
  
• Paid vacation days
  
• Paid holidays