Senior Complaint & Quality Specialist

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Contract Type:  2-year contract (Temporary or Incorporated)

Role Summary

The Lead Investigator will oversee product complaint investigations and trend analyses for medical devices, combination products, and drug delivery systems. This role supports both clinical trials and commercial products, playing a crucial part in identifying product quality issues, evaluating trends, and implementing corrective and preventive actions to maintain consistent product and manufacturing quality.

Primary Responsibilities

Lead investigations for both critical and non-critical product complaints with limited supervision.

Develop investigation plans and ensure reports are thorough, accurate, and compliant with company and regulatory standards.

Handle global complaints related to products that are manufactured, packaged, labeled, or distributed through clinical and commercial supply chains.

Initiate, review, approve, and close complaint records in the Quality Management System (including Complaints, Deviations, CAPAs, etc.).

Evaluate potential failure modes and risk impacts to determine root causes.

Draft, review, and approve CAPAs, ensuring timely resolution of quality issues.

Cross-Functional Collaboration & Leadership

Collaborate with global teams across Manufacturing, Packaging, Device Quality, Supply Chain, and Affiliates to drive efficient investigations.

Lead root cause analysis sessions and present findings at Quality Review Boards (QRBs).

Act as the Quality representative on cross-functional and multi-site initiatives.

Provide mentorship and training on complaint management and quality processes.

Trend Analysis & Continuous Improvement

Analyze complaint data to detect trends, emerging risks, and potential reporting or recall requirements.

Develop and maintain risk metrics and CAPA trend analyses for management review.

Identify opportunities to enhance complaint and quality system processes.

Assist with audits, regulatory inspections, and quality reporting tasks.

Additional Duties

Communicate with patients and healthcare professionals as necessary.

Support quality system initiatives, including batch record reviews and continuous improvement projects.

Monitor complaint activity and elevate urgent issues to management.

Education & Experience

Bachelor’s degree (or higher), ideally in Life Sciences.

8+ years of experience in pharmaceutical, biopharmaceutical, or medical device environments.

Strong technical writing abilities.

Deep understanding of medical devices, combination products, and drug delivery systems.

Experience with drug substance and drug product manufacturing processes (small and large molecules).

Proficiency with quality tools such as Six Sigma / DMAIC.

Experience working in global, matrixed organizations.

Familiarity with enterprise quality systems, collaboration platforms, and analytics tools.

Thorough knowledge of GMP, Quality Systems, global regulatory standards, and Health Authority expectations.

Proven experience managing complaints, investigations, CAPAs, and sample reconciliation.

Strong analytical, statistical, and critical-thinking skills.

Clear and professional written and verbal communication; fluent in English.

Ability to collaborate and influence without formal authority.

Strong stakeholder management skills and relationship-building across global teams.

Continuous improvement mindset with Lean and Agile approaches.

Proactive, accountable, and comfortable working independently on complex challenges.

Additional language skills are an advantage.

Seniority level
Mid-Senior level

Employment type

Full-time

Job function
Quality Assurance

Industries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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