Quality Manager

About QTS

QTS offers critical end‑of‑line services for medical device OEMs, including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at  and

QTS provides end‑of‑line services for medical device OEMs, managing finished device assembly, packaging and sterilization. It is part of the Cretex Medical family of companies.

QTS is seeking an experienced, energetic, well‑organized full‑time Quality Manager. The role will build, manage and lead the quality department staff, partnering with sales, engineering, procurement and operations to ensure the highest possible quality products within the QTS Quality Management System.

• Establish and lead a high‑performing team of Quality Engineers, Quality Technicians and Customer‑Facing Quality, providing mentorship and coaching.
• Manage customer quality communication and relationships, assisting in resolution, documentation and customer responses for complaints.
• Execute quality policies, objectives and plans that support corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements.
• Ensure effective coordination of investigations, root‑cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions within adhered timelines.
• Maintain professional and timely cross‑functional communication with other departments and customers.
• Monitor and assess QMS processes for compliance, effectiveness and opportunities for improvement, ensuring product meets requirements and continued certification to applicable standards.
• Maintain Quality System Dashboards, Scorecards and key performance indicators for product quality, reviewing trends and communicating issues to department management.
• Assure in‑process inspection, batch record review, sterile and product release compliance with the quality system.
• Support the Management Review process and drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root‑cause corrective action.
• Support a culture of Operational Excellence, inclusive of lean and six‑sigma principles.
• Act as the Deputy Management Representative as needed.
• Act as a representative for customer audits and support external audits by regulatory authorities and registration agencies.

• Bachelor’s degree in Engineering, Sciences, Quality or relevant experience.
• 8 years of experience in Quality or Engineering in a manufacturing setting in a regulated field.
• 5 years of leadership experience.
• Clear and effective verbal and written communication skills.
• Strong attention to detail and organizational skills.
• In‑depth knowledge of 13485, 14971, FDA Quality System Regulation, 21
  
  CFR Part 820 and GMP.
• Experience with Corrective and Preventative Actions, including leading cross‑functional teams to solve problems and complete root‑cause analysis.
• Working knowledge of quality tools, variable and attribute sampling plans, DOE, statistics, Lean Manufacturing and Six‑Sigma.
• Demonstrated leadership skills with the ability to build, mentor and maintain an efficient organization focused on continual improvement.
• Experience with finished device manufacturing.
• Ability to prioritize, plan and evaluate deliverables to established strategic goals and timelines.

• Continuing education through local chapters, associations or other organizations.

• “I would describe my coworkers as kind and friendly.”
• “… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction.”
• “Three words that I would use to describe QTS’s culture are:
  Respectful, Fast‑paced, and Fun!”

USD $97,900.00 – $ per year.

• All employees: 401(k) retirement savings plan with company match; onsite health clinics; discretionary holiday bonus;
  Cretex University; 24/7 employee assistance program; wellness program; employee death benefit and sick and safe leave.
• 20+ hours:…