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Job Description
Director of Quality at Maclivaro Limited Director of Quality at Maclivaro Limited in aurora, Colorado Posted in 9 days ago.
Type:
full-time
Job Description:
Director of Quality Location:
Colorado, USA (On-Site)
Salary:
$140,000 - $170,000 + Benefits Director of Quality - Growing Medical Device Company We are partnering with an innovative and rapidly growing medical device company seeking a Director of Quality to join its leadership team and play a pivotal role in shaping the next phase of growth. This is an exciting opportunity for a quality leader who thrives in a fast-paced environment and wants to make a genuine impact. The successful candidate will be responsible for driving quality strategy, strengthening operational excellence, ensuring regulatory compliance, and building a culture where quality is embedded in everything the organization does. We're looking for more than technical expertise. We want someone who is humble, courageous, transparent, and people-focused-a leader who can inspire teams, challenge constructively, and help create an environment where employees are empowered to do their best work. About the Opportunity As Director of Quality, you will provide both strategic leadership and hands-on guidance across all quality functions. Working closely with Executive Leadership, Engineering, Operations, Manufacturing, and Regulatory teams, you will ensure the business continues to scale while maintaining the highest standards of quality and compliance. This role is ideal for someone who enjoys building, improving, and influencing. You'll have the opportunity to shape systems, processes, teams, and culture while helping the company achieve its ambitious growth objectives. Key Responsibilities Leadership & Culture Champion a quality-first culture throughout the organization. Lead, mentor, and develop the Quality team, fostering accountability, engagement, and continuous learning. Partner with leadership to align quality objectives with broader business goals. Act as a trusted advisor and advocate for quality across all departments. Drive a culture built on collaboration, transparency, ownership, and continuous improvement. Quality Systems & Compliance Own and continuously improve the Quality Management System (QMS). Ensure ongoing compliance with FDA regulations and applicable quality standards. Lead quality planning activities to support business growth and operational excellence. Develop and monitor quality metrics, KPIs, and reporting mechanisms. Audits & Regulatory Readiness Lead internal, supplier, customer, and regulatory audit activities. Ensure audit readiness and successful outcomes during inspections. Manage CAPA systems, root cause investigations, risk assessments, and corrective actions. Support regulatory activities and partner with regulatory teams on compliance initiatives. Engineering & Operations Partnership Collaborate closely with Engineering and Manufacturing teams throughout the product lifecycle. Support product development, design controls, process validation, risk management, and change control activities. Drive quality improvements across manufacturing and operational processes. Ensure quality considerations remain at the forefront of business decision-making. Continuous Improvement Identify opportunities to improve systems, processes, and performance. Lead quality improvement initiatives that enhance compliance, efficiency, customer satisfaction, and business performance. Utilise data and metrics to drive informed decision-making and measurable outcomes. What We're Looking For Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline. Significant leadership experience within the Medical Device industry . Proven experience leading Quality functions in a regulated environment. Strong expertise in Quality Management Systems (QMS). In-depth knowledge of FDA regulations and medical device quality requirements. Extensive auditing experience, including regulatory and supplier audits. Strong understanding of Engineering, Manufacturing, Design Controls, Validation, Risk Management, CAPA, and Change Control. Experience building and developing high-performing teams. Excellent communication and stakeholder management skills.
The Person You are:
A leader who leads by example. Comfortable operating strategically while remaining hands-on when needed. Humble enough to listen and learn. Courageous enough to challenge and drive change. Transparent, authentic, and trustworthy. Passionate about developing people and building strong teams. Energized by growth, innovation, and continuous improvement. Committed to helping create a world-class medical device organization. Why Join? Join a growing company where your impact will be visible and meaningful. Influence strategy and help shape the future of the organization. Work alongside an ambitious and collaborative leadership team. Build a culture that prioritizes quality, innovation, and people. Competitive salary of $140,000 - $170,000 plus benefits. If you're an experienced quality leader looking for an opportunity to drive excellence, influence culture, and help scale a growing medical device business, we'd love to hear from you.
