Senior Quality Engineer

Codon Partners; Boston (MA); Híbrido; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Codon Partners Ltd. is seeking an experienced Quality Engineer to support quality assurance and compliance in a medical device manufacturing environment. The role focuses on maintaining quality systems, supporting manufacturing operations, and investigations to ensure ongoing regulatory compliance.

You will collaborate with cross-functional teams on improvements and sustainable solutions. The position offers exposure to established processes and new product development activities in a hybrid

Qualificações

• Bachelor's degree in Engineering or related field.
• ≥3 years in quality engineering or QA in medical devices.
• Experience with CAPA, change control, deviations, and audits.
• Knowledge of ISO 13485 and GMP requirements.
• Familiarity with ISO 14971 risk management and FDA QMS.
• Experience applying eQMS and product development processes.

Responsabilidades

• Oversee CAPA, change management and nonconformance investigations.
• Assess processes for regulatory requirements and internal procedures.
• Support administration and improvement of the eQMS.
• Review quality docs: SOPs, reports, validation records.
• Identify compliance gaps and remediation plans.
• Coordinate internal audits and regulatory inspections.
• Manage audit findings and corrective actions.
• Lead root cause investigations and action recommendations.
• Apply statistics to monitor process performance.
• Collaborate with Manufacturing, Engineering and Product teams.

Conhecimentos

CAPA management

Change control

Deviation investigations

Audit activities

Problem solving

Data-driven quality improvement

Communication

Quality documentation

Formação académica

Bachelor's degree in Engineering or related field

Ferramentas

eQMS

Descrição da oferta de emprego

We are seeking an experienced Quality Engineer to support quality assurance and compliance activities within a medical device manufacturing environment. This position will focus on maintaining and improving quality systems, supporting manufacturing operations, managing quality-related investigations, and ensuring ongoing compliance with applicable industry regulations and standards. Working alongside cross-functional teams, the successful candidate will help identify opportunities for improvement, resolve quality issues, and support the implementation of effective, sustainable solutions. The assignment offers exposure to both established manufacturing processes and new product development activities.

Key Responsibilities

Quality Systems & Compliance

• Oversee and support quality management activities, including corrective and preventive actions (CAPAs), change management, and nonconformance investigations.
• Assess quality processes and documentation to ensure alignment with applicable regulatory requirements and internal procedures.
• Support the administration and continuous improvement of electronic Quality Management Systems (eQMS).
• Review and approve quality documentation, including operating procedures, technical reports, validation records, and associated controlled documents.
• Identify compliance gaps and contribute to the development and execution of appropriate remediation plans.

Audits & Investigations

• Coordinate and participate in internal audits, customer assessments, and regulatory inspections.
• Manage audit findings and associated corrective actions, ensuring that commitments are completed within agreed timelines.
• Lead or support investigations into quality issues, using structured problem-solving and root cause analysis techniques.
• Prepare investigation documentation and recommend actions to prevent recurrence.
• Monitor the effectiveness of implemented corrective and preventive measures.

Manufacturing & Process Quality

• Collaborate with Manufacturing, Engineering, Operations, and Product Development teams to maintain consistent product quality.
• Evaluate manufacturing processes and contribute to initiatives aimed at improving reliability, efficiency, and compliance.
• Support equipment qualification, process validation, and periodic revalidation activities.
• Apply statistical techniques to evaluate process performance, identify trends, and establish appropriate process controls.
• Assist with the development and maintenance of systems for monitoring and analysing quality and manufacturing data.
• Provide quality engineering input throughout relevant stages of product development and design transfer.
• Support the review of product requirements, design documentation, and verification and validation activities.
• Contribute to risk management activities in accordance with ISO 14971, ensuring that identified risks are appropriately evaluated, controlled, and documented.
• Work with technical teams to ensure that quality and regulatory considerations are incorporated into product and process decisions.
• Identify opportunities to strengthen quality processes and improve operational effectiveness.
• Support initiatives to address compliance deficiencies and improve existing quality practices.
• Provide technical guidance and knowledge sharing to other members of the quality team.
• Contribute to additional quality improvement projects as required.

Experience & Qualifications

• Bachelor's degree in Engineering, a relevant scientific discipline, or equivalent professional experience.
• At least 3 years of experience in quality engineering or quality assurance within the medical device industry.
• Practical experience working in a regulated manufacturing environment.
• Demonstrated involvement in CAPA management, change control, deviation investigations, and audit activities.
• Sound understanding of ISO 13485 and applicable Good Manufacturing Practice (GMP) requirements.
• Working knowledge of medical device risk management principles under ISO 14971.
• Familiarity with FDA quality system requirements and relevant international medical device regulations.
• Experience supporting process validation, quality documentation, and manufacturing quality activities.
• Knowledge of statistical process control and data-driven quality improvement techniques.
• Strong analytical, investigation, and problem-solving abilities.
• Ability to prepare clear technical documentation and communicate effectively with internal stakeholders.
• Experience using electronic Quality Management Systems (eQMS).
• Familiarity with medical device design controls and product development processes.
• Exposure to EU MDR and other international regulatory frameworks.
• Understanding of continuous improvement methodologies, including Lean or Six Sigma.
• Experience working on quality remediation or compliance improvement projects.
• Previous experience supporting regulatory or customer inspections.

Working Arrangements

This opportunity is offered on a hybrid consulting basis, combining remote working with on-site activities where required.

The successful candidate should be comfortable taking responsibility for assigned deliverables, working with limited supervision, and collaborating with engineering, manufacturing, and quality stakeholders.

The role will suit someone who can balance hands‑on technical problem‑solving with broader quality system and compliance responsibilities.

Applications are welcomed from suitably qualified individuals of all backgrounds. Recruitment decisions will be based on relevant skills, experience, qualifications, and suitability for the position. Reasonable adjustments can be accommodated throughout the recruitment process.