💼 About This Role

You'll support new product development and design control for molecular biology products in an ISO 13485-compliant QMS. Your work ensures high-quality, compliant product launches for a fast-growing genomics company. This role offers exposure to cross-functional teams and global quality systems.

🎯 What You'll Do

• Provide design control guidance to new product development teams.
• Review and approve design control documentation and activities.
• Participate in project milestone and review gates.
• Lead internal audits and support external audits as SME.

📋 Requirements

• Bachelor's degree in molecular biology or related field.
• 5+ years of quality assurance and product development experience under design controls.
• Working knowledge of molecular biology or genomics applications.
• Experience with ISO 13485 or similar regulated QMS.

✨ Nice to Have

• ISO 13485, ISO 9001, or cGMP industry experience.
• Audit experience (internal or external).
• Project management experience.

🎁 Benefits & Perks

• 🏖️ Flexible Time Off and holidays.
• 💰 Bonus + equity eligibility.
• 🏥 75% employer-paid medical with buy-up options.
• 🦷 Employer-paid dental and vision.
• 📈 401(k) with 4% match.

📨 Hiring Process

Submit letter of motivation and CV via company website; interviews require three professional references.