BioTalent
This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $100,000.00/yr - $115,000.00/yr
Additional compensation types Annual Bonus
Role We’re seeking a
hands‑on and detail‑oriented Quality Engineer
to join our growing Quality Assurance and Regulatory Affairs team. The ideal candidate will have a strong engineering background with experience across the full product lifecycle—from design through manufacturing—within the medical device industry.
This individual will play a key role in shaping and strengthening our Quality Management System (QMS), with opportunities to lead validation, process improvement, and regulatory readiness initiatives.
Role & Responsibilities
Partner with R&D to define product requirements and release criteria; support design reviews and ensure robust technical documentation.
Lead
risk management activities (FMEA/DFMEA/PFMEA)
and maintain traceability throughout the design process.
Author, maintain, and execute
design verification and validation (V&V)
protocols and reports; lead
hands‑on test method validations (TMVs)
and formal V&V testing.
Execute and document
intended‑use and computer system validations , ensuring systems meet regulatory and business needs.
Drive
QMS remediation and continuous improvement initiatives —identify procedural or documentation gaps proactively, develop and implement sustainable fixes, and ensure alignment with FDA QMSR and ISO 13485.
Draft, revise, and maintain
SOPs and quality procedures ; support internal audits, CAPA, and monitoring of quality metrics.
Contribute to
regulatory submissions
(e.g., 510(k), Letters to File, labeling, technical documentation) and ensure compliance with global regulatory standards.
Oversee
supplier qualification , conduct supplier audits, and drive supplier corrective and preventive actions (SCARs).
Develop inspection plans; support inventory control, equipment/tool calibration, and
process validation (IQ/OQ/PQ)
activities.
Collaborate across Operations, Manufacturing, and Supply Chain to communicate risks, mitigations, and timelines effectively.
Mentor junior team members and help foster a culture of continuous learning and improvement.
Requirements
Bachelor’s degree in Engineering or a related technical field.
2–4 years of quality engineering experience
in the medical device or diagnostics industry (additional experience considered for Senior title).
Working knowledge of
FDA QMSR, ISO 13485, ISO 14971 , and experience with lifecycle documentation in regulated environments.
Proven experience in
QMS remediation or enhancement —demonstrated ability to identify process or documentation gaps and implement proactive, scalable solutions.
Hands‑on validation experience (e.g.,
developing and executing TMV, IQ/OQ/PQ, and process validation
activities).
Preferred familiarity with
510(k) submissions
and/or
EU MDR
technical documentation.
Exposure to
early‑stage or startup environments
where adaptability and cross‑functional collaboration are key.
Strong technical writing, attention to detail, and data‑driven problem‑solving skills.
Excellent communication and stakeholder management skills; able to clearly articulate findings, risk assessments, and recommendations.
Ambitious, career‑driven, and self‑motivated —someone with a clear vision for their professional growth and the drive to make an impact in a scaling organization.
Seniority level Associate
Employment type Full‑time
Job function Quality Assurance and Engineering
Industry Medical Equipment Manufacturing
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Base pay range $100,000.00/yr - $115,000.00/yr
Additional compensation types Annual Bonus
Role We’re seeking a
hands‑on and detail‑oriented Quality Engineer
to join our growing Quality Assurance and Regulatory Affairs team. The ideal candidate will have a strong engineering background with experience across the full product lifecycle—from design through manufacturing—within the medical device industry.
This individual will play a key role in shaping and strengthening our Quality Management System (QMS), with opportunities to lead validation, process improvement, and regulatory readiness initiatives.
Role & Responsibilities
Partner with R&D to define product requirements and release criteria; support design reviews and ensure robust technical documentation.
Lead
risk management activities (FMEA/DFMEA/PFMEA)
and maintain traceability throughout the design process.
Author, maintain, and execute
design verification and validation (V&V)
protocols and reports; lead
hands‑on test method validations (TMVs)
and formal V&V testing.
Execute and document
intended‑use and computer system validations , ensuring systems meet regulatory and business needs.
Drive
QMS remediation and continuous improvement initiatives —identify procedural or documentation gaps proactively, develop and implement sustainable fixes, and ensure alignment with FDA QMSR and ISO 13485.
Draft, revise, and maintain
SOPs and quality procedures ; support internal audits, CAPA, and monitoring of quality metrics.
Contribute to
regulatory submissions
(e.g., 510(k), Letters to File, labeling, technical documentation) and ensure compliance with global regulatory standards.
Oversee
supplier qualification , conduct supplier audits, and drive supplier corrective and preventive actions (SCARs).
Develop inspection plans; support inventory control, equipment/tool calibration, and
process validation (IQ/OQ/PQ)
activities.
Collaborate across Operations, Manufacturing, and Supply Chain to communicate risks, mitigations, and timelines effectively.
Mentor junior team members and help foster a culture of continuous learning and improvement.
Requirements
Bachelor’s degree in Engineering or a related technical field.
2–4 years of quality engineering experience
in the medical device or diagnostics industry (additional experience considered for Senior title).
Working knowledge of
FDA QMSR, ISO 13485, ISO 14971 , and experience with lifecycle documentation in regulated environments.
Proven experience in
QMS remediation or enhancement —demonstrated ability to identify process or documentation gaps and implement proactive, scalable solutions.
Hands‑on validation experience (e.g.,
developing and executing TMV, IQ/OQ/PQ, and process validation
activities).
Preferred familiarity with
510(k) submissions
and/or
EU MDR
technical documentation.
Exposure to
early‑stage or startup environments
where adaptability and cross‑functional collaboration are key.
Strong technical writing, attention to detail, and data‑driven problem‑solving skills.
Excellent communication and stakeholder management skills; able to clearly articulate findings, risk assessments, and recommendations.
Ambitious, career‑driven, and self‑motivated —someone with a clear vision for their professional growth and the drive to make an impact in a scaling organization.
Seniority level Associate
Employment type Full‑time
Job function Quality Assurance and Engineering
Industry Medical Equipment Manufacturing
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