Director, Quality Systems & Compliance (Devices & Combination Products)

Job Description

Director, Devices & Combination Products Complaints QA

We are seeking a highly motivated and experienced Director of Combination Products Complaints QA to join our team.  This role is responsible for leading and supporting the complaints management processes for combination products with a focus on auto-injectors, pre-filled syringes and other innovative drug delivery systems.  The ideal candidate will have a strong background and deep expertise in complaint management systems, regulatory reporting and post-market surveillance for combination products.

The ideal candidate should also have a proven track record of establishing and managing compliant, scalable complaint processes across pharma, biotech or medical device sectors, and will play a key leadership role in ensuring regulatory compliance, patient safety, and continuous improvement of device complaint quality systems.

Key Responsibilities:

• Establish and maintain robust complaint handling processes specific to combination products such as auto-injectors and pre-filled syringes
• Develop and refine complaint categories tailored to device related issues to support effective trending and risk management
• Lead and support complaint investigations coordinating with cross-functional teams (e.g. Manufacturing, Technical Operations, Device Development, Safety and Regulatory) ensuring timely completion and CAPA implementation
• Ensure compliance with post-market safety reporting criteria for combination products
• Maintain and improve quality systems in alignment with combination product requirements under 21 CFR Part 4, QMSR, ISO 13485, EU MDR and other OUS regulations
• Represent the company in audits and inspections as the subject matter expert for combination product complaints
• Provide quality oversight of complaint data trending and escalation processes, including preparation of management review metrics, quarterly summaries and regulatory reporting decisions with links into risk assessments and CAPAs as needed
• Collaborate with Pharmacovigilance and Regulatory Affairs on reportable events and periodic safety updates
• Provide expert interpretation of regulations and quality standards related to complaint handling for combination products
• Drive continuous improvement initiatives across complaint processes, systems and team capabilities

Qualifications, Skills & Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related field
• 5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries with at least 3 years’ experience focused on combination products complaints
• Strong understanding of post-market surveillance, global safety reporting and regulatory requirements for combination products, including FDA, EMA, and other health authority guidelines.
• Strong understanding of ISO 13485, ISO 14971, QMSR, Part 4, and other relevant standards.
• Proven track record in leading cross-functional teams
• Excellent communication, leadership, and problem-solving skills.

Preferred Skills & Experience

• Experience in building and scaling global complaint handling systems
• Proficiency with electronic systems (e.g. Trackwise) and tools for handling complaints
• Experience integrating complaint and safety data into product lifecycle and risk management strategies

Extent of Travel

Less than 20% travel to US/OUS

Management or Individual Contributor           

Individual Contributor

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans an