US Quality Assurance Specialist - Savannah, GA

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS
—Our organization works with partner companies to source qualified talent for their open roles. This position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click submit and follow the steps. All positions are onsite unless otherwise stated. Don’t just work somewhere;

join Brasseler and be a valued team member of a world‑class health care organization!

We provide a safe and welcoming environment where team members can balance their lives and develop their careers. All people and experiences are valued and respected; different perspectives are encouraged, leading to better results. This is who we are and enables us to be a world‑class healthcare organization. All who join us are accountable to this charge.

Quality products sold with integrity is the hallmark of Brasseler USA. We’ve been providing high‑quality, clinician‑endorsed, innovative dental and medical instrumentation for over 40 years, offering a full range of products made in the USA since 1976. Many are manufactured at our headquarters in Savannah, GA.

This position will be the key Quality resource and responsible for all quality assurance aspects and support of implementing and supporting an automated medical device manufacturing line. It covers a wide range of Quality Systems regulatory requirements and related activities to support a medical device manufacturing line, including regulatory affairs, procedure development, and coordination with departments to meet quality system requirements.

• Provide Quality support in the development, implementation and monitoring of a new automated manufacturing line.
• Review records and documents for completeness and compliance with Quality System Requirements and ISO requirements.
• Assist in company‑wide training on general quality principles and specific procedural requirements.
• Teach and lead others in developing quality skills.
• Assist in developing standard operating procedures and work instructions for the new manufacturing line.
• Initiate quality system process improvement.
• Manage and maintain Quality System documents and records.
• Support the Corrective Action program, owning investigation and resolution of issues.
• Assist, coordinate and participate in quality system audits and regulatory inspections.
• Support the Material Review Board for assessment and disposition of non‑conforming materials and closure of Non‑conformance and Deviation Reports.
• Investigate quality problems.
• Conduct process quality measurements and evaluations.
• Assist in monitoring, analyzing and reporting trends in key quality metrics.
• Ensure established department timelines are attained.
• Complete other activities as assigned by the Manager of QA/RA.

465586

Bachelors

Operations

• Providing quality support to a medical device manufacturing line with little supervision.
• Relevant experience in the medical device industry.
• Familiarity with FDA medical device regulations and ISO 13485.
• Experience in QA support of automated medical device manufacturing.
• Experience with 3D Printing and Thermoforming a plus.
• Experience in Process Validations (IQ, OQ, PQ).

• Bachelor’s Degree (preferred) and four years related experience.

• Read and interpret general technical/quality procedures and quality system regulations.
• Write and create medical device manufacturing SOPs and Work Instructions.
• Create reports, business correspondence, and procedure manuals.
• Effectively present information verbally, in writing, and in group presentations.
• Skillful in Microsoft Word, Excel, Outlook and Power Point.

• Travel—typically not required.
• Position typically works in an office environment, on site or remote, with stable environmental conditions.
• Duty requires sitting for extended periods, using hands for…