Overview
Tester / 1st Shift Jobs in Easley, SC at Danfoss
Job Summary
Evolve MedTech Partners is a medical device development company and incubator. We partner with companies, inventors, physicians, and investors to quickly and efficiently bring ideas from conception to licensing, acquisition, or commercialization. Early-stage medical device companies are launched, co-located, and supported by Evolve or other entrepreneurs from the Evolve facility. The team provides leadership and know-how at all stages of product and commercial development, leveraging our vast experience and past successes to rapidly innovate and develop medical devices. Evolve and its extended team have experts in product development, intellectual property strategy, regulatory and quality, manufacturing, commercialization, clinical, and business development. Under the direction of the Project Manager and the Quality Engineer, the Associate Quality Engineer will be responsible for working with cross-functional teams to execute direction from the Company’s Quality efforts on new and existing devices. The position is responsible for the day-to-day execution of all Quality operations activities.
Responsibilities
To perform this job successfully, an individual must be able to perform each essential function satisfactorily:
Support the development of the Company’s quality objectives and will work in conjunction with the company’s personnel to ensure ISO/QSR compliance.
Participate in regulatory and quality audits as required to maintain ISO/QSR compliance.
Collaborate with internal and external partners (e.g. laboratories, manufacturers, and packagers) to ensure the development, manufacture, and distribution of medical devices that meet quality and regulatory requirements for new and existing products.
Work with product development and operations to qualify raw material, component, and product specifications and drawings.
Contribute to the company’s risk management program such as hazards analyses, DFMEA, AFMEA, PFMEA to be compliant with ISO 14971
Support the generation of compliant product labeling, instructional and promotional materials per FDA and MDR EU 2017/745.
Create and complete product design verification and validation tests and activities.
Perform all administrative activities associated with the department. This will include executing change orders, assessing non-conformances, writing test protocols/reports, creating material and product inspection instructions, and more.
Actively comply with Evolve’s Quality System.
Evolve Medtech Partners is an entrepreneurial environment and each employee may be asked to assist in work areas outside their usual duties.
Education and Experience:
Four-year degree, preferably in engineering, physics, or a related degree required. Preferred 0-2 years’ experience in supporting and participating in quality system management and compliance.
Skills and Abilities:
The ideal candidate will possess the following qualifications:
Experience with or understanding of FDA QSR compliance, specifically 21 CFR 820 and ISO 13485. Experience in FDA inspections is a plus.
Ability to generate and review high quality documentation to support 510(k) and/or PMA submissions.
Excellence in organizational management with the ability to develop high performance teams.
Demonstrate strong leadership, team building, and advanced coaching skills to motivate people, assess, and develop employee skills.
Makes quality decisions in real-time according to regulations and procedures.
Team-oriented individual with strong interpersonal skills, facilitating effective communication with clients, supervisors, colleagues, and staff.
Strong leadership, excellent organizational skills, and a good blend of discipline and creativity.
Solid analytical skills and the ability to problem-solve quickly.
Excellent organizational and time management skills to effectively and efficiently structure work and projects to achieve timely progress on multiple simultaneous tasks, meet deadlines, and maintain a high level of productivity.
Skilled in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
Job Type: Full-time
Benefits:
401(k)
Health insurance
Paid time off
Schedule:
8 hour shift
Monday to Friday
Ability to Commute:
Solana Beach, CA 92075 (Required)
Work Location: In person
Title: Tester / 1st Shift
Company: Danfoss
Location: Easley, SC
