Quality Assurance Manager

Avetix TIC; Massachusetts; Sur place; USD 110 000 - 170 000; Plein temps

Résumé du poste

Avetix TIC is a growing medical device company focused on a platform for interventional GI procedures. You’ll lead the day-to-day Quality function and partner across Development, Manufacturing, Regulatory, and leadership to maintain the QMS and drive compliant product and process decisions.

You will own the quality system, oversee CAPA, NCRs, audits, supplier quality, and post-market surveillance, and ensure risk-based, data-driven resolution of issues while enabling timely product delivery.

Qualifications

• 8+ years in Quality Engineering or Quality Assurance within the medical device industry, with increasing responsibility.
• Strong working knowledge of 21 CFR Part 820 / QMSR, ISO 13485 and ISO 14971.
• Hands‑on experience with design controls, risk management, V&V, design transfer, process validation and change control.
• Experience with NCRs, CAPA, root‑cause investigation, complaint handling and supplier quality.
• Experience reviewing and approving technical quality records, with strong technical writing skills.
• Proven ability to manage a broad Quality workload independently in a small or cross‑functional organisation.
• Confidence engaging senior leaders, engineers, production teams, suppliers, auditors and regulators.
• Bachelor’s degree in Engineering, Life Sciences or a related discipline (or equivalent experience)

Responsabilités

• Lead the Quality function hands‑on, setting priorities and maintaining and improving the QMS (procedures, records, training, document control)
• Provide Quality Engineering support across design controls, risk management, verification/validation, design transfer and change control
• Support manufacturing quality, including process validation (IQ/OQ/PQ), inspection and test method qualification, and production controls
• Own or facilitate nonconformance, CAPA and investigation processes, from root cause through to effectiveness checks
• Provide Quality oversight of complaint handling, returned‑product evaluation and post‑market trending, working with Regulatory on reportability decisions
• Establish risk‑based supplier controls, including qualification, monitoring and supplier corrective actions
• Keep the company inspection‑ready, supporting internal, customer and external audits and regulatory inspections
• Develop quality metrics and support Management Review

Connaissances

Quality leadership

Cross-functional collaboration

Risk management

Technical writing

Formation

Bachelor’s degree in Engineering, Life Sciences or related discipline

Outils

QMS (MasterControl)

Description du poste

A growing, innovative medical device company developing a platform for interventional gastrointestinal procedures. The system combines a reusable control module with a portfolio of single-use catheters in multiple sizes and configurations.

The role

You’ll lead the day-to-day Quality function and act as a trusted, independent Quality partner across Design & Development, NPI, Manufacturing, Regulatory, Commercial Operations and senior leadership. You’ll own and continually improve the quality system, approve product and process activities, and drive practical, risk‑based resolution of quality issues in a small organisation.

This suits someone who is comfortable making sound decisions when information is incomplete, who works constructively with teams to find a compliant path forward, and who has the confidence to pause an activity when a real quality, compliance or patient‑safety concern remains unresolved.

Key responsibilities

• Lead the Quality function hands‑on, setting priorities and maintaining and improving the QMS (procedures, records, training, document control)
• Provide Quality Engineering support across design controls, risk management, verification/validation, design transfer and change control
• Support manufacturing quality, including process validation (IQ/OQ/PQ), inspection and test method qualification, and production controls
• Own or facilitate nonconformance, CAPA and investigation processes, from root cause through to effectiveness checks
• Provide Quality oversight of complaint handling, returned‑product evaluation and post‑market trending, working with Regulatory on reportability decisions
• Establish risk‑based supplier controls, including qualification, monitoring and supplier corrective actions
• Keep the company inspection‑ready, supporting internal, customer and external audits and regulatory inspections
• Develop quality metrics and support Management Review

Must‑have experience

• 8+ years in Quality Engineering or Quality Assurance within the medical device industry, with increasing responsibility
• Strong working knowledge of 21 CFR Part 820 / QMSR, ISO 13485 and ISO 14971
• Hands‑on experience with design controls, risk management, V&V, design transfer, process validation and change control
• Experience with NCRs, CAPA, root‑cause investigation, complaint handling and supplier quality
• Experience reviewing and approving technical quality records, with strong technical writing skills
• Proven ability to manage a broad Quality workload independently in a small or cross‑functional organisation
• Confidence engaging senior leaders, engineers, production teams, suppliers, auditors and regulators
• Bachelor’s degree in Engineering, Life Sciences or a related discipline (or equivalent experience)