US Quality Assurance Specialist - Brasseler

Henry Schein•Savannah, GA

About The Position

Don’t just work somewhere, join Brasseler and be a valued team member of a world-class health care organization! Our Culture: Provides 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 and lead to better results. This makes us who we are and enables us to be a world-class healthcare organization. All who join us are accountable to this charge. Our Philosophy: Quality products sold with integrity has been the hallmark of Brasseler USA from the beginning. Brasseler USA’s strong reputation of providing high quality, clinician endorsed and innovative dental and medical instrumentation nationally has spanned over 40 years. We have been offering a full-range of products made in the USA since 1976. Many of our products are manufactured at our headquarters in Savannah, GA. Explore our career opportunities below to learn more. JOB OVERVIEW: 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. This position is responsible for a wide range of Quality Systems regulatory requirements and associated quality activities to support a medical device manufacturing line. The person assists in investigating and supporting regulatory affairs activities, assists in the development of procedures, and coordinates with different departments to ensure quality system requirements are met.

Requirements

Providing quality support to a medical device manufacturing line with little supervision.
Relevant experience in the medical device industry is required.
Familiarity with FDA medical device regulations and ISO 13485 is required.
Experience in QA support of automated medical device manufacturing.
Ability to read and interpret general technical/quality procedures and quality system regulations.
Ability to write and create medical device manufacturing SOPs and Work Instructions.
Ability to create reports, business correspondence, and procedure manuals
Ability to effectively present information and respond to questions verbally, in writing, and in group presentations
Must be skilled in Microsoft Word, Excel, Outlook and Power Point

Nice To Haves

Experience with 3D Printing and Thermoforming a plus.
Experience in Process Validations (IQ, OQ, PQ)
Bachelor’s Degree (preferred) and four years related experience.

Responsibilities

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