Quality Technician II - 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.

Quality Control Technician II Ideal Candidate Profile

QTS is currently seeking an energetic, responsive and well-organized full time Quality Control Technician II. This position will be responsible for leading the completion of the nonconforming event process and conduct production in-process documentation audits. This role will also complete appropriate quality records within company and GMP guidelines, policies, and procedures.

Responsibilities

Quality Control Technician II Job Summary

• Create/revise Quality Management System (QMS) procedures and documentation.
• Develop and implement plans to ensure the ongoing compliance of QMS.
• Lead periodic cross-functional reviews of line and paperwork audit program.
• Lead NCMR process and MRB meetings.
• Manage MRB Cage.
• Provide support for CAPA investigations, actions, and effectiveness assessments.
• Report to management on the status of NCMR and line/paperwork audits.
• Support the development and maintenance of a Global Quality System model that scales with organizational growth.
• Identify training gaps and support the development of QMS training materials to promote quality awareness and ensure compliance with company policies and procedures.
• Assist with the implementation of quality system improvements.
• Assist with issue resolution with regards to the Quality System software.
• Assist with the issuance, investigation, and closure of Non-Conformance Reports, Complaints, and CAPAs about the Quality System software.
• Assist with second and third-party audits, including audit preparation, execution, reporting, and follow-up activities CQS Role.
• Assist the internal audit program and the implementation of effective corrective actions.
• Document process audits and communicates results with Operations.
• Assist Document Control.
• Work with Operations and/or Quality to resolve manufacturing documentation issues.
• Recommend changes to quality documentation.
• Ability to train Quality Technician I personnel.

Qualifications

Quality Control Technician II Skills and Experience

• High school diploma or general education degree (GED) required.
• At least 5 years of experience in a quality-related role.
• Knowledge of inspection equipment use and maintenance.
• Problem solving and analysis.
• Manage multiple requirements and deadlines.
• Mechanical aptitude, dexterity and hand and eye coordination.
• Ability to use a microscope and hand tools
• Ability to cross-train in other areas of production when required.
• 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.

Desirable Criteria & Qualifications

• Associate Degree or equivalent work experience.
• 5+ years of experience in quality assurance.
• Knowledge of ISO 9001/13485.
• Quality Technician or Quality Assurance certifications.
• ISO 13485 Internal Auditor Certification.
• 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 t