Quality Control Manager

Company Description:

We are a data-driven dental chip manufacturing company with high growth potential, looking for a talented quality control manager to help us ensure and create top-of-the-line MyDentalWig devices and products.

Join our Quality Systems team, where our mission is to ensure compliance with relevant regulatory standards. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations.

Job Responsibilities:

• Conduct audits of GLP, GMP, GCP, and engineering activities within MyDentalWig ensuring adherence to U.S. FDA regulatory requirements, applicable standards, and MyDentalWig policies.
• Identify and define audit scope and criteria, review evidence, and analyze findings to assess compliance levels. Provide recommendations for improvement and corrective actions as needed.
• Perform root cause analysis to identify compliance gaps and risks, providing results to leadership for further action.
• Drive process improvements to enhance systemic compliance and quality standards, utilizing ingenuity and creative problem-solving skills.
• Assist with deviation and audit findings, tracking, ensuring their effective execution, and coordinating timely closure of actions.
• Lead the front room for external audits i.e., FDA or other notified bodies.

Key qualifications:

• Bachelor’s degree in a relevant scientific or healthcare field.
• 4+ years of experience as an auditor.
• Experience being in the front room for external audits (FDA or other notified bodies).
• Strong quality assurance and analytical skills.
• Excellent communication and collaboration abilities.
• Experience with regulatory and technical writing.

Preferred qualifications:

• Engineering background.
• Experience with international regulatory audits (TGA, EU, Health Canada, MDSAP).
• Experience with supplier audits
• Experience leading an internal audit program

Pay Transparency:

Based on California law, the following details are for California individuals only:

California base salary range: 

$90,000—$111,205 USD

For full-time employees, your compensation package will include two major components: salary and vested stock options. Guidance on salary for this role will be determined according to the level you enter the organization (with the ability to gain more through time as you contribute).

Full-Time Employees are eligible for equity and benefits listed below in addition.

Benefits:

• cashless stock options
• Climbing the ladder fast
• 401K
• Health- Vision and Dental when company reaches 10 full-time staff

Schedule:

• Day shift
• Monday to Friday

Ability to Relocate:

• Lancaster, CA 93536: Relocate before starting work (Required)

Work Location: In person