Quality Engineer - Auburndale, MA
19 hours ago
Job description
Job Title:
Quality Engineer (Medical Device)-
(USC/GC Only)
Pay Rate:
$65 to $70/hr
Duration:
12 months
Location:
Newton, MA
We are looking for a Quality Engineer (Medical Devices).
- Serve as the Quality representative and
Design Controls
lead on cross-functional teams developing complex
electromechanical
and
robotic medical
systems. - Own and support
Design Control activities
across the product lifecycle in accordance with
FDA QSR
(
21 CFR
,
ISO 13485
, and applicable regulations. - Support definition and approval of system- and subsystem-level design inputs that are clear, testable, and aligned to intended use and risk.
- Maintain end-to-end traceability between design inputs, outputs,
risk
controls,
verification
, and
validation
. - Support design reviews, phase gate readiness, and Design History File (
DHF
) completeness. - Lead and support
risk management
activities per
ISO
using a system-level, top-down, and bottom-up approach. - Ensure risk controls are implemented and verified, and residual risk is supported by objective evidence.
- Support tolerance, worst-case, and margin analyses as inputs to risk assessment and verification planning.
- Provide Quality oversight of
design verification and validation
(V&V) planning, execution, and reporting. - Review and approve V&V protocols and reports to ensure adequate coverage of requirements, risks, and regulatory expectations.
- Support electrical safety and EMC compliance testing, including IEC , IEC , and IEC , as applicable.
- Collaborate with Software Quality and Systems Engineering to ensure HW/SW integration risks are addressed.
- Support supplier qualification and design transfer for design-critical components and interfaces.
- Support preparation and review of
Design Control
,
risk
, and V&V documentation for IDE, De Novo, and/or PMA submissions.
Sustaining Activities-
- Supporting the collection and analysis of performance metrics.
- Proposing and leading Corrective and Preventive Actions (
CAPAs
). - Leading and/or participating in product complaint investigations leading to root cause.
- Assisting in the disposition of non-conforming material.
- Supporting other duties as assigned by the manager.
Requirements:
- Minimum 4-year degree in Engineering, Biomedical Engineering, or Life Sciences.
- 7 to 10 years of experience as a
Quality or Design Quality Engineer
in the
medical device
industry supporting the development of complex
electro-mechanical Class III
devices is required. - Working knowledge of
QSR, MDD/MDR
,
ISO
, and ISO-14971 is required. - Experience supporting the development of compliant medical device software or
SaMD
(i.e,
IEC 62304/82304
) and
SWFMEA
development is required. - Experience in applied statistics, including the use of
Minitab
or other
statistical
analysis software, is required. - Experience in
CAPA, NCMR
, and complaint investigations is required. - Familiarity with electrical component handling and
ESD
controls is required.
Experience with supporting De Novo/PMA submissions is preferred.
- Effective and professional communication skills with both internal and external stakeholders.
- Effective written communication skills, with the ability to author clear, concise, and accurate procedures, analyses, protocols, and reports.
- Effective time/task management skills; excel in working in a fast-paced environment.
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