Responsibilities:

• Lead and manage the Quality Affairs team.
• Develop, enhance, and maintain processes and procedures to ensure consistent, high-quality product designs and manufacturing.
• Oversee timely and effective incoming inspections, collaborating with suppliers to drive quality improvements.
• Build strong partnerships across R&D, manufacturing, marketing, sales, and regulatory teams.
• Ensure full compliance with relevant FDA and ISO standards.

Qualifications:

• Bachelor’s degree in Engineering or Science.
• 8 years of relevant experience in a regulated industry (preferably Medical Devices).
• 2 years of experience in directly supervising a quality team.

Desired Knowledge, Skills, and Abilities:

• Strong problem-solving and critical thinking abilities.
• Excellent written and verbal communication skills.
• High sense of urgency and commitment to continuous improvement.
• Demonstrated leadership presence.
• Experience with Oracle is a plus.

Compensation and Benefits:

• Annual salary of $125,000-$140,000
• 10% variable compensation based on MBOs.
• Medical/Dental insurance – 75% covered for both employees and family members.
• Vision Insurance.
• Basic Life and AD&D coverage.
• 401(k) with a 4% employer match.
• Unlimited vacation policy.
• 10 paid holidays.
• 6 weeks of paid maternity leave.
• Work in a dynamic environment surrounded by talented and engaged colleagues.