Quality Engineer Contractor (6 months)

Dandy is transforming the massive ($200B) but antiquated dental industry. Backed by some of the world's leading venture capital investors, we are on an ambitious mission to integrate and simplify every function of the dental practice through technology. By building the operating system for every dental office in America, Dandy is empowering dentists with technology, innovation, and world-class support to achieve more for their practice, their people, and their patients.

About Us:
We are a growing leader in the dental manufacturing industry, committed to delivering high-quality products to our customers. With a strong emphasis on innovation and excellence, we are seeking an experienced Quality Contractor to lead our site’s efforts in achieving ISO 13485 compliance and obtaining MDSAP certification to enable shipping dental products into Canada.

Position Summary:
We are looking for a results-driven quality professional to spearhead the effort to achieve ISO 13485 compliance and coordinate the regulatory activities required for an MDSAP certification. This contractor will work closely with cross-functional teams to ensure all quality management system (QMS) requirements are met, oversee audits, and facilitate the regulatory processes necessary to obtain a Canadian medical device license.

Key Responsibilities:

• ISO 13485 Compliance:

  • Lead the development and implementation of a compliant QMS.

  • Identify gaps in current processes and create corrective action plans.

  • Provide training and guidance to staff on ISO 13485 requirements.

• MDSAP Certification:

  • Coordinate and manage all activities to prepare for MDSAP certification audits.

  • Work with third-party auditors and regulatory bodies to address requirements.

  • Oversee documentation, including technical files, risk management, and validation protocols, to ensure compliance with MDSAP requirements.

• Medical Device License for Canada:

  • Facilitate the submission of required documentation to Health Canada.

  • Ensure product labeling and packaging meet regulatory standards.

  • Act as the point of contact for regulatory agencies during the application process.

• Collaboration & Leadership:

  • Collaborate with manufacturing, engineering, and quality teams to ensure alignment on compliance objectives.

  • Lead internal audits and prepare the site for external inspections.

  • Report progress to senior leadership and provide recommendations for resource allocation.

Qualifications:

• Proven experience in achieving ISO 13485 certification and/or MDSAP compliance.

• Strong knowledge of regulatory requirements for medical devices, including Health Canada’s licensing process.

• Experience leading quality assurance initiatives in a manufacturing environment, preferably in dental or medical devices.

• Ability to interpret and apply international standards and regulations.

• Strong project management skills with the ability to manage timelines and resources effectively.

• Excellent communication and leadership abilities to engage cross-functional teams.

Preferred Qualifications:

• Previous experience working with medical device licensing in Canada.

• Certification in quality management (e.g., CQE, CQA, or similar).

• Familiarity with risk management standards (ISO 14971) and validation processes.

Location: Lehi, UT
Duration: ~6 months (Contract Position)
Start Date: ASAP
Compensation: Competitive, commensurate with experience

For full time positions, we offer a wide range of best in class, comprehensive and inclusive employee benefits including healthcare, dental, parental planning, mental health benefits, a 401(k) plan, and paid time off.

Dandy is proud to be an equal-opportunity employer. We are committed to building a diverse and inclusive culture that celebrates authenticity to win as one. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, citizenship or immigration status, or any other legally protected characteristics.

Dandy also fully complies with the Americans with Disabilities Act (ADA). We are dedicated to embracing challenges and creating an accessible, inclusive workplace for all individuals. If you require any accommodations for your interview or have any questions beforehand, rest assured that we will move at Dandy speed and do everything in our power to meet your needs.