This position is responsible for assisting the Manager of QA/RA in handling a wide range of Quality Systems regulatory requirements and associated quality activities in our dental and medical businesses. 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.
- 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 the development of standard operating procedures to define and improve quality system functions.
- 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
- Assist in the completion of necessary information and submits documents required to register products, obtain licenses, report adverse events, and other submissions as directed by the Manager of QA/RA.
- Facilitate process improvement within other departments, through the use of training, coaching, and team participation.
- Conduct process quality measurements/evaluations
- Interacts with Product Management to assist and coordinate required submission documentation
- 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
- Relevant experience in the medical device industry is preferred.
- Familiarity with FDA medical device regulations preferred.
- Familiarity with ISO 13485, CMDR and EUMDD preferred.
KNOWLEDGE, SKILLS & COMPETENCIES:
- Associates Degree and four years related experience.
TRAVEL / PHYSICAL DEMANDS:
- Ability to read and interpret general technical/quality procedures and quality system regulations.
- 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
- Travel typically less than 10%. Office environment. No special physical demands required.
- Job demands may require long periods of sitting, standing, telephone work, and computer work
- Job demands may require occasional heavy lifting, up to 15 pounds.
Brasseler USA is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.