Associate Manager, QA

We are seeking an Associate Manager, QA to join our dynamic and fast-paced team. This role is perfect for someone who is a self-starter, brings an energetic outlook, and can hit the ground running. You will lead a team of Quality Engineers, guiding them to enhance and maintain quality processes in alignment with regulatory requirements and business strategies.

As a key player in our Quality Assurance team, you will drive continuous improvement initiatives, foster strong relationships with stakeholders, and ensure the highest levels of quality and compliance.

Let's talk about Responsibilities:

• Lead a team of Quality Engineers, ensuring policies, processes, and metrics align with business strategy and regulatory standards.

• Manage resource allocation to meet quality, delivery, and cost objectives.

• Foster a highly engaged, self-empowered team through mentorship and leadership.

• Provide technical guidance to ensure best practices and compliance with industry standards.

• Oversee risk management processes and ensure alignment across operations.

• Support and participate in internal and external audits, including regulatory system audits.

• Manage product and performance non-conformances with a focus on root cause analysis and corrective/preventive actions.

• Drive continuous improvements in the quality system and data reporting mechanisms.

• Build strong business partnerships with key stakeholders to support operational performance.

• Contribute to new product development and process improvements.

• Ensure compliance with quality standards, regulatory requirements, and business systems.

• Implement and monitor management systems in areas like health & safety, quality, and environmental management.

Let's talk about Qualifications & Experience:

Required:

• Bachelor’s degree with at least 5 years of experience in Quality, Regulatory, or Manufacturing Engineering within a QMS in a regulated industry (e.g., medical devices, pharmaceuticals).

• Strong knowledge of GMP, ISO 13485, FDA regulations, and other global quality standards.

• 1-3 years of people management experience in a similarly regulated industry.

• Proven ability to resolve key quality issues and manage competing priorities in a fast-paced environment.

• Exceptional leadership, collaboration, and communication skills.

Preferred:

• Experience with high-volume manufacturing processes.

• Familiarity with total quality management (TQM), Lean, 5S, and Six Sigma methodologies.

• Experience with process validation and risk management techniques.

Why Join Us?

• Be part of a collaborative and innovative team.

• Opportunity to make an immediate impact and drive continuous improvement.

• Competitive compensation and benefits.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!