Job Summary: The Quality Engineer is responsible for QA manufacturing, supplier management program, and calibration program. The QA Engineer provides the necessary support and guidance to ensure t that all applicable quality standards are met in accordance with regulatory requirements and company policies for all Dynex products and systems.
Essential Functions: The Quality Engineer maintains FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) supplier evaluation and approval, calibration program and QA manufacturing support.
• Conduct risk analysis related to the systems being supported.
• Conduct Internal / External audits and generate audit reports.
• Oversight of all non-conformities related to the manufacturing operations area.
• Generate and review trend data reports and metrics as required.
• Oversight of Supplier Management Program.
• Oversight of the Calibration Program.
• Member of the Non-conforming MRB (Material Review Board).
• Other duties as assigned.
Supervisory Responsibilities: None.
Success Factors: Must be a Team Player, Ability to communicate effectively with all levels of technical and professional personnel. Excellent problem-solving skills. Adaptable to change and ability to multi-task. Must possess a hands-on approach that encourages improvement.
Computer Skills: Basic Microsoft Office suite skills, MS Project.
Work Environment: Office.
Minimum Qualifications / Education: B.S. Degree in Engineering or any science related field preferred, 3 years related experience in regulated industry in lieu of degree will be considered. Broad knowledge 21 CFR 820, ISO 13485, ISO 14971. The ideal candidate will also possess Quality Auditor qualification.
Physical Requirements: Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.
Additional Benefits/Compensation Offered:
Vision Benefits and more
401K w/ Matching Company Contribution
13 Paid Special Leave/Holidays Annually
Company Provided Life Insurance, Short-Term, and Long-Term Disability
DYNEX Technologies, Inc. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. DYNEX Technologies provides medical, dental, life and disability insurance, Section 125, 401(k), flexible schedules, educational assistance and a great work environment!
Visit our website www.dynextechnologies.com.
*No Recruiters please.