Eyenovia is an exciting medical device start-up company with a job opportunity based in Reno, NV. Eyenovia offers a competitive benefits package including medical, dental, PTO, and holidays. Visit www.eyenovialab.com to learn more.
Position Title: Quality Engineer
Department: Quality Assurance
FLSA Status: Exempt
JOB SCOPE AND DIMENSIONS:
The Quality Engineer ensures the quality system requirements are effectively maintained in accordance with 21 CFR 820 and ISO 13485. The Quality Engineer receives direction from the Quality Manager.
Examples of Essential Functions:
Including but not limited to:
Participate in the product development and risk management processes. Work with design engineering in the completion of product verification and validation
Perform document control activities including establishing and maintaining the controlled document files and document log and processing document change orders.
Receive and process complaints, maintain complaint files.
Maintain corrective and preventive action system (CAPA), nonconforming materials system, supplier qualification, record control, calibration system, training matrix and training files.
Manage activities required for sterilization validations.
Review lot history records and release finished goods for human use.
Inspect components, product subassemblies, and finished goods
Perform all other assigned duties as necessary.
QUALIFICATIONS GUIDELINES: Any combination equivalent to, but not limited to, the following:
Education/Training/Experience: Minimum of Bachelor of Science (BS) in Engineering from an accredited college or university with 2 years experience, preferably in medical device or other regulated industry.
Preferred: Meets minimum requirements plus ASQ Certification (e.g. CQA, CBA, CQE, etc.).
Knowledge/Skills/Abilities: Demonstrated knowledge of Quality Assurance; preferred experience in medical device design and manufacturing.
Expertise in Microsoft Office applications.
Excellent written and verbal communication and interpersonal skills. Ability to work collaboratively across all functional groups and all levels.
Highly motivated, goal orientated achiever with ability to prioritize and organize own work independently.
Excellent problem-solving skills.
Proficiency with written and spoken English. Excellent organization skills.
To apply for this position, submit your resume to firstname.lastname@example.org.