Quality Assurance Engineer II
JenzabarSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries
Requirements
- Bachelor’s degree in Engineering (Industrial, Biomedical, or related field)
- Minimum 2 years of quality engineering experience in a regulated medical device manufacturing environment
- Proficient in ISO 13485, 21 CFR 820, and design control requirements
- Hands-on experience with process validation (IQ/OQ/PQ), CAPA, FMEA, and DHR review
- Familiarity with risk management per ISO 14971
- Strong analytical, documentation, and problem-solving skills
- Preferred Qualifications
- Experience with radiological or electromechanical medical devices
- Familiar with engineering drawings and GD&T
Responsibilities
- Ensure compliance with FDA 21 CFR 820 and ISO 13485 during manufacturing and inspection processes
- Lead and support process validation activities (IQ/OQ/PQ), test method validations (TMV), and equipment qualifications
- Review and approve Device History Records (DHRs) for completeness and compliance prior to product release; identify and resolve discrepancies
- Maintain DHR templates to ensure accurate documentation of manufacturing activities
- Manage manufacturing nonconformance records and CAPAs; lead root cause investigations and implement effective corrective/preventive actions
- Develop and maintain manufacturing quality documentation including inspection procedures and work instructions
- Conduct line audits and floor inspections to verify adherence to Good Manufacturing Practices (GMPs) and internal quality standards
- Participate in internal and external audits and support timely responses to observations/findings
- Maintain and update PFMEAs and participate in risk assessments related to process changes and product quality
- Collaborate with cross-functional teams including Engineering, Operations, and Regulatory Affairs during NPI and design transfer
- Monitor process performance through data analysis and statistical tools to support continuous improvement initiatives
- Responsible for incoming inspections
- Support supplier quality activities and product release processes
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Manufacturing Quality Engineer position?
This information is not specified in the job description.
Is this a remote position or does it require in-person work?
This is an in-person position.
What are the required qualifications for this role?
Candidates need a Bachelor’s degree in Engineering (Industrial, Biomedical, or related field), minimum 2 years of quality engineering experience in a regulated medical device manufacturing environment, proficiency in ISO 13485 and 21 CFR 820, hands-on experience with process validation (IQ/OQ/PQ), CAPA, FMEA, and DHR review, familiarity with ISO 14971, and strong analytical, documentation, and problem-solving skills.
What kind of company is OXOS Medical?
OXOS Medical builds radiographic imaging devices like the MC2 Portable X-Ray System to improve image quality, reduce radiation, enhance ease of use, and enable radiologic diagnostics anywhere.
What experience makes a strong candidate for this Manufacturing Quality Engineer role?
Strong candidates will have at least 2 years in medical device quality engineering with hands-on experience in process validation, CAPA, FMEA, DHR review, and regulatory standards like ISO 13485 and 21 CFR 820; a relevant engineering degree is required.
OXOS Medical
Develops handheld digital radiographic instruments
About OXOS Medical
The company specializes in advanced radiographic technology with its handheld dynamic digital radiographic instrument, the Micro C. This device is distinguished by its compact design, high-resolution imaging capabilities, and lower radiation exposure, making it both safe and effective for use in diverse clinical and surgical environments. By prioritizing technological advancements in medical imaging, the company not only leads in safety and efficiency but also supports critical healthcare applications, making it a promising workplace for those interested in contributing to significant medical innovations.
Atlanta, GeorgiaHeadquarters
2016Year Founded
$36.5MTotal Funding
SERIES_ACompany Stage
Biotechnology, HealthcareIndustries
51-200Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
Company Equity
Risks
Emerging competitors may impact OXOS's market share.
FDA approval delays could hinder product launches.
Rising raw material costs may affect profit margins.
Differentiation
OXOS offers radiographic instruments requiring minimal training, enhancing accessibility.
Their cloud-based platform integrates telehealth, revolutionizing healthcare delivery.
OXOS enables point-of-care diagnostics, expanding radiologic access globally.
Upsides
Growing demand for portable imaging devices boosts OXOS's market potential.
AI integration enhances diagnostic accuracy, complementing OXOS's platform.
Telehealth market growth aligns with OXOS's strategic direction.
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