Job Title: Quality Engineer
Company: Novozen Health Care LLC.,
Location: Danevrs, MA
Employment Type: Contract
Job Responsibilities:
A skilled independent worker comfortable with translating compliance requirements into ways of working (document content generation) - we need someone who can write and/or facilitate redlines
Comfortable investigating and documenting quality records
Comfortable with excel (data mining, lookups, etc)
Comfortable auditing quality records for compliance
Comfortable learning and navigating quality systems
Nice to Have Skills & Experience
-Experience supporting service and repair or commercial quality operations
-Exposure to global or multi site quality environments
-Experience with computer system validation or quality IT systems
-Familiarity with ISO 14971, EU MDR, or MDSAP
-Six Sigma or other continuous improvement methodology experience
-Master s degree in engineering, science, or business
Day-to-Day
-Provide quality support for service and repair operations, including nonconformances, CAPAs, change controls, and escalations
-Partner with operations teams to ensure compliance with medical device quality systems and regulatory requirements
-Support internal and external audits and inspections related to service and repair activities
-Help implement and improve quality processes, SOPs, and systems aligned with industry standards
-Identify quality risks, support issue resolution, and drive continuous improvement initiatives
-Collaborate cross functionally with quality, operations, supply chain, and commercial teams
Required Qualifications:
-Bachelor s degree in Engineering or a scientific discipline
-5+ years of experience in a regulated industry, preferably medical devices
-Hands on experience with quality systems such as CAPA, nonconformance, change control, and audits
-Knowledge of medical device regulations (FDA QSR, ISO 13485, etc.)
-Strong communication skills and ability to work cross functionally in a fast changing environment
-Detail oriented, self directed, and comfortable managing multiple priorities
Pay Scale:
Anticipated hourly pay range: specific range such as ($39/Hr to $46/Hr).
Benefits:
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.
Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.