Senior Quality Engineer, Device Quality

Syncromune • Fort Lauderdale, FL

5d • Hybrid

About The Position

The Senior Quality Engineer will be primarily responsible for Risk Management and process assurance for the lifecycle of a Class III medical device product from design & development through phase exits and commercialization. This professional will work with the device teams to ensure that products meet stringent safety and regulatory requirements in target geographies. This role will serve as the quality engineering representative for ISO 14971 Risk Management, establishing quality system requirements, and ensuring system level alignment with vendor, supplier, and CDMO quality activities. The role will collaborate closely with the Engineering and R&D teams on internal development and documentation activities as well as oversight of manufacturing and testing partners. Principal Duties and Responsibilities include the following: The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management. Support the administration and continuous improvement of the global quality management system (QMS) for high risk (Class III) medical device products. Participate in product development as a member of the Product Development Team, and provide support as needed for creation of engineering reports, test plans, test protocols, and test report, as needed. Risk Management & Analysis: Lead and facilitate risk assessment activities, including PFMEA (Process Failure Mode and Effects Analysis), DFMEA (Design FMEA), and Hazard Analysis to identify and mitigate potential patient risks. Process Validation (V&V): Ensure appropriate Supplier Quality Management. Provide Quality oversight to suppliers in the planning and execution of validation protocols for manufacturing processes, equipment, and tooling, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). CAPA & Investigation: Drive the Corrective and Preventive Action (CAPA) process by leading root cause investigations into product non-conformities, customer complaints, and audit findings. Device Failure Investigation: Support the investigation and documentation of device failure cases reported from clinical studies. Regulatory Compliance: Act as a subject matter expert for FDA 21 CFR 820 and ISO 13485 standards (now harmonized), ensuring the Design and Development Files and Medical Device File are compliant and audit-ready. Support the attainment and maintenance of ISO 13485 certification and CE Mark. Supplier Quality: Evaluate and audit suppliers and CMOs to ensure raw materials, components, and finished devices meet specified quality standards. Perform on-going monitoring of suppliers and CMOs, and drive corrective actions through the SCAR process. Statistical Analysis: Apply advanced statistical tools to analyze production data, monitor trends, and establish appropriate sampling plans. Cross-Functional Leadership: Represent the quality function in cross-functional teams, providing technical guidance to R&D and engineering. Support and co-host GXP-focused audits, inspections, and assessments of product in partnership with Quality Management for auditors including, but not limited to: Notified Bodies Regulatory Authorities Customers Potential partners. Ensure alignment between the QMS requirements and external design & development and manufacturing quality activities, maintaining clear process ownership between Vendors/ Suppliers and QA.

Requirements

• Bachelor's degree in Engineering, Medical Technology, life sciences, or related scientific discipline required.
• At least 5 years of progressively responsible experience in quality engineering within the medical device/ med tech industry, with Class III products a strong preference.
• High degree of technology proficiency and fluency in Engineering platforms.
• Excellent project management skills with ability to manage multiple priorities in a fast-paced environment.
• Commitment to integrity, ethics, and quality culture development.
• Outstanding written and verbal communication skills with ability to influence at different organizational levels both internally and with Vendor/ Contractor/ Supplier partners.
• Demonstrated ability to work collaboratively across functions and across geographies, and skill in building effective partnerships for successful outcomes.
• Proactive mindset, providing recommendations to Leadership based on anticipated compliance challenges and industry trends.

Nice To Haves

• Advanced degree preferred.
• Professional certifications such as ASQ Certified Quality Engineer (CQE) or other GXP certification a plus.

Responsibilities

• Support the administration and continuous improvement of the global quality management system (QMS) for high risk (Class III) medical device products.
• Participate in product development as a member of the Product Development Team, and provide support as needed for creation of engineering reports, test plans, test protocols, and test report, as needed.
• Risk Management & Analysis: Lead and facilitate risk assessment activities, including PFMEA (Process Failure Mode and Effects Analysis), DFMEA (Design FMEA), and Hazard Analysis to identify and mitigate potential patient risks.
• Process Validation (V&V): Ensure appropriate Supplier Quality Management.
• Provide Quality oversight to suppliers in the planning and execution of validation protocols for manufacturing processes, equipment, and tooling, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• CAPA & Investigation: Drive the Corrective and Preventive Action (CAPA) process by leading root cause investigations into product non-conformities, customer complaints, and audit findings.
• Device Failure Investigation: Support the investigation and documentation of device failure cases reported from clinical studies.
• Regulatory Compliance: Act as a subject matter expert for FDA 21 CFR 820 and ISO 13485 standards (now harmonized), ensuring the Design and Development Files and Medical Device File are compliant and audit-ready.
• Support the attainment and maintenance of ISO 13485 certification and CE Mark.
• Supplier Quality: Evaluate and audit suppliers and CMOs to ensure raw materials, components, and finished devices meet specified quality standards.
• Perform on-going monitoring of suppliers and CMOs, and drive corrective actions through the SCAR process.
• Statistical Analysis: Apply advanced statistical tools to analyze production data, monitor trends, and establish appropriate sampling plans.
• Cross-Functional Leadership: Represent the quality function in cross-functional teams, providing technical guidance to R&D and engineering.
• Support and co-host GXP-focused audits, inspections, and assessments of product in partnership with Quality Management for auditors including, but not limited to: Notified Bodies Regulatory Authorities Customers Potential partners.
• Ensure alignment between the QMS requirements and external design & development and manufacturing quality activities, maintaining clear process ownership between Vendors/ Suppliers and QA.

Benefits

• This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees