Quality Specialist

Job Description

Do you have a passion for helping bring innovative medical devices and drug delivery products to market that improve patient lives? Sanner America (previously known as Gilero) is seeking a Quality Specialist to support our Pittsboro, NC facility. You will be responsible for supporting the transition between development and commercial manufacturing activities of medical devices and drug delivery devices and ensuring quality excellence.

You'll work M-F, 8 hours per day (flex 9am-5pm, 8am-4pm, or 7am-3pm your choice). We are willing to train the right candidate who desires to grow with Gilero and be part of our team.

Duties:

• Liaise between product development and manufacturing project teams to ensure compliant design transfer
• Coordinate, assemble, and route documentation per quality system lifecycle requirements
• Perform incoming inspection/testing and release of accepted materials
• Perform pilot builds in cooperation with operations and design transfer teams
• Conduct labeling verification in accordance with product requirements
• Perform in-process testing and QA inspections per product requirements
• Coordinate environmental monitoring, including particle counts and temperature/humidity/pressure measurements
• Coordinate cleaning of controlled environment areas per internal procedures
• Manage third-party environmental testing and approve results
• Support sterilization coordination
• Review batch records for accuracy and completeness. Collaborate with manufacturing and development teams to resolve any batch documentation-related errors or gaps
• Support quality event initiation and investigation for nonconformances, CAPA, change control and complaints.
• Support continuous improvement projects and audits

Skills/Qualifications:

• Bachelor’s degree or equivalent combination of education and experience.
• 1 - 3 years in regulated manufacturing environment
• Experience with FDA 820 CFRs/ISO 13485/cGMP quality management system requirements and medical devices/combination product development
• Basic experience with coordination of GMP compliant Documents, Records, and Training
• Strong written and verbal communication skills

Preferred:

• 3+ years in medical device manufacturing
• Experience with quality operations, design transfer and GxP concepts
• Experience with GMP manufacturing operations and process development
• ASQ or related certification

Personal Attributes:

• Meets Sanner America Core Values:
  Collaboration, Innovation, Excellence, Integrity
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Sanner America does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why Sanner America?

Headquartered in Durham, North Carolina, Sanner America is the North American business of the Sanner Group and an end-to-end partner for medical devices, drug delivery systems, and healthcare packaging. Carrying forward the Gilero legacy of more than two decades of medical device design, development, and manufacturing, our teams take products from concept to commercialization. Our culture is built on collaboration, transparency, agility, and shared success, united by the Sanner Group purpose:
Protecting Health. US locations include Carlsbad, CA;
Chicago, IL; and Durham, Greensboro, and Pittsboro, NC, with additional operations in Mexico.

Sanner America offers an annual bonus plan; three BCBS medical plans; dental and vision coverage; company-provided life insurance, short- and long-term disability; paid maternity and parental leave; a 401(k) match beginning the first month after hire with no vesting period; and access to Linked In Learning, with over 21,000 courses and certifications for personal and professional development.

Become part of a team motivated by compassion and a shared commitment for making a meaningful impact on patients, caretakers, and consumers everywhere!