Staff / Senior Staff Advanced Manufacturing Engineer, MedTech
Knowles Precision Devices
Quality Assurance Specialist
Frida
full-time
Posted on:
Origin: • 🇺🇸 United States • Florida
Visit company websiteJob Level
JuniorMid-Level
About the role
- Maintain QMS procedures, forms, records, and training; ensure controlled documents are current and effective
- Manage filing, access, retrieval, and retention periods for records and documents
- Review Quality System Records for conformance and compliance
- Author, review, and approve SOPs, work instructions, forms, and controlled logbooks
- Execute product release activities, verify required documentation, manage holds and dispositions, and escalate deviations as needed
- Establish and improve product and process quality through individual and team-based problem-solving using industry best practices
- Prepare for and participate in internal and external audits and inspections; track findings to closure
- Identify opportunities for improvement, recommend solutions, and drive implementation
- Collaborate with Engineering and Quality departments during product development to ensure compliance throughout design and manufacturing processes
- Review Engineering Change Orders related to design, engineering, or manufacturing
- Partner with internal auditors and quality managers on compliance-related matters
- Provide support on development projects and regulatory issues to ensure timely submissions for market clearance
- Collaborate cross-functionally to drive continuous improvement in yield, defect reduction, and customer experience
Requirements
- Bachelor’s degree in engineering, Science, or another technical field
- 2+ years of relevant experience, ideally within the medical device, cosmetics, or other regulated industries
- Familiarity with regulatory requirements strongly preferred (e.g., FDA, ISO 9001, ISO 13485, GMP)
- Energetic, positive team player who thrives in an entrepreneurial environment
- Strong advocate for product excellence and quality
- Analytical skills with the ability to make data-driven decisions and communicate effectively
- Highly organized with the ability to manage multiple priorities and tasks with strong attention to detail
- Ability to identify opportunities, recommend improvements, and implement solutions
- Strong written and verbal communication skills
