Quality Systems Specialist - Quality Tech Services, LLC

Overview

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 www.qtspackaging.com and www.cretexmedical.com.
Responsibilities

Quality Systems Specialist Ideal Candidate Profile

QTS is currently seeking an energetic, responsive, and well-organized full time Quality Systems Specialist that will be responsible for developing, implementing, and maintaining the quality management system.

Quality Systems Specialist Job Summary

• Lead second and third-party audits, including audit preparation, execution, reporting and follow-up activities.
• Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions. The audit program is responsible for maintaining and improving a quality system which meets the requirements ISO 13485, and FDA QSR.
• Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques.
• Provide leadership in Company regulatory matters and support customers regarding their regulatory needs.
• Develop and maintain a Global Quality System model that scales with organizational growth.
• Support, lead and coordinate supplier audits.
• Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits.
• Identify, develop, and maintain relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures.
• Partner with quality and operations to implement quality system improvements.
• Implement, maintain, and provide issue resolution in regard to the Global Quality System software.
• Support and comply with the company Quality System, ISO, and medical device requirements.
• Partner with document control team to ensure compliance to quality system and regulatory requirements.

Qualifications

Quality Systems Specialist Skills and Experience

• Bachelor's degree in a related field.
• 3 years of experience working with quality management systems.
• Experience with ISO 13485:2016 and FDA.
• Lead Auditor Certification.
• Front room audit experience for external and third-party audits.
• Ability to consistently achieve short- and long-term business results.
• Ability to prioritize work and manage multiple tasks when needed.
• Ability to follow through on commitments and hold team members accountable.
• Consistently produces work that meets the customer's requirements.
• Focus on Operational Excellence.
• Project management skills.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills
• Attention to detail and organizational skills.
• Ability to work in a fast-paced team environment.
• Ability to prioritize and multitask.
• Ability to work in a manufacturing environment.
• Ability to travel up to 15%.

Desirable Criteria & Qualifications

• Quality systems experience in a manufacturing setting.
• Continuing education; including participation in local chapters, associations, and/or organizations.

What Is It Like to Work for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS:

• "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 associated with it. All in all, a good fun ride so far and I can't wait to keep it going!"
• "Three words that I would use to describe QTS's culture are: Respectful, Fast-paced, and Fun!"

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

QTS Benefits:

As a Cretex Medical company, QTS offers a full benefit package to its employe