QA Operations Manager

In this position you will be asked to:

• Manage a team that includes Quality Engineers and QC/QA Coordinators, providing guidance, support, and training.

• Engage with production processes closely, gaining an in-depth understanding of the production line in a clean room, with a strong commitment to practical, on-the-ground quality management.

• Identify operational weaknesses and drive the team to implement effective solutions.

• Work closely with the Director of Operations to ensure alignment on quality and production goals.

• Change Control Oversight (ECO): Manage Engineering Change Orders (ECOs) and guide Quality Engineers through the implementation of these changes.

• Environmental Monitoring: Serve as the primary authority on cleanroom standards, performing daily monitoring and alerts for any microbial deviations.

• Calibration and Maintenance: Overseen activities execution and process improvement.

• Suppliers control: Overseen suppliers qualification process and performance

• Update and align QA procedures, approvals, and signatures as needed.

• Enhance contract review processes, ensuring quality expectations are met.

• Deepen the sterilization knowledge of Quality Engineers to ensure comprehensive quality checks.

• Cross-functional Involvement: Participate in key forums such as ECO, complaints, and CAPA (Corrective and Preventive Actions), and proactively create additional forums to improve cross-functional communication.

A successful candidate will have the following qualifications:

• Experience: Minimum 5 years in team management of at least 5 employees and at least 5 years in medical device quality assurance.

• Leadership: Proven ability to lead improvement processes, with a strategic mindset capable of seeing the broader business impact.

• Technical Knowledge: Extensive QA expertise coupled with solid technical knowledge.

• Education: Background in life sciences or engineering.

• Cleanroom Experience: Hands-on experience in a cleanroom setting within the medical device industry.

• Regulatory Experience: In-depth knowledge of FDA audits and notified body inspections.

• Preferred Experience: Background in sterile product manufacturing or with implantable medical devices is a plus.

Personal Attributes

• Systematic Thinking: Ability to grasp complex systems and drive process improvements.

• High Intelligence: Quick to understand new concepts and adept at technical problem-solving.

• Interpersonal Skills: Strong communication and collaboration skills, with a down-to-earth approach.

• Continuous Improvement Orientation: Strives for ongoing improvement while maintaining existing standards.

• Creativity and Initiative: Flexible, solution-oriented mindset, unafraid to think outside the box.

• Attention to Detail: Precise, organized, and able to prioritize effectively under pressure.

• Business Insight: Connects quality processes to broader business goals.