Quality Assurance Specialist

As a Quality Assurance Specialist at Flex you will be at the forefront of strengthening our quality systems and ensuring that our OTC Class II medical devices cosmetics and dietary supplements meet the highest standards of safety efficacy and compliance. Reporting to the Director of Regulatory Affairs & Quality Assurance you will take ownership of critical quality functions including document and change control product risk management CAPA complaint handling and audit support. By collaborating closely with crossfunctional teams you will provide procedural guidance enforce quality standards and contribute to a culture of regulatory excellence.

This is a dynamic role for a detailoriented analytical professional who thrives in fastpaced environments and is passionate about learning and applying regulatory standards. Your work will directly impact the quality and safety of our products while driving continuous improvement across processes and systems. If youre seeking an opportunity to combine technical rigor handson and collaboration to make a tangible difference this position is your chance to shape the future of our category and contribute meaningfully to our mission.

Salary range: $6580k per year commensurate with experience.

Key Responsibilities:

• Ensure Compliance: Uphold conformance to internal SOPs and applicable external regulatory requirements including FDA ISO and cGMP standards.
• Technical Deliverables Management: Execute and manage quality and regulatory documentation such as risk management files procedural documents change requests and product specifications.
• Risk Analysis: Conduct and manage risk assessments to support the development manufacturing and postmarket surveillance of safe highquality products.
• CAPA : Lead and manage Corrective and Preventive Actions (CAPA) ensuring timely investigation root cause analysis and implementation of effective solutions.
• Complaint Handling & Regulatory Reporting: Oversee the investigation and resolution of product complaints and ensure accurate and timely reporting to regulatory authorities when required.
• Continuous Improvement: Identify opportunities for improvement within quality systems and processes implementing changes to enhance compliance and operational efficiency.
• CrossFunctional Collaboration: Collaborate with internal teams (Supply Chain Product Development Marketing) and external suppliers to maintain product quality and regulatory compliance.
• Quality System Guidance: Educate and guide crossfunctional team members on quality systems regulations and procedural compliance.
• Audit and Inspection Support: Prepare and support internal and external audits ensuring readiness and compliance with quality standards.

Key Performance Indicators:

• Timely complaint handling and reporting
• Timely corrective and preventive action management
• Employee QMS training success (ex: ontime completion and passing success rates)

Requirements:

• Minimum of 23 years of handson regulated quality systems and product manufacturing experience
• Medical device or pharmaceutical quality systems experience preferred
• Strong skills in analyzing data and processes to recommend improvements
• Ability to learn and stay updated on industry regulations and standards
• Excellent followthrough and attention to detail while focusing on the most important priorities
• Stellar technical writing and verbal communication skills

In 1 Month You Will:

• Complete onboarding and get familiar with Flexs structure quality systems and key regulatory requirements for OTC Class II medical devices cosmetics and dietary supplements.
• Review current quality documents change control processes and risk management practices noting areas for improvement.
• Build strong relationships with teams like Supply Chain Product Development Marketing and Contract Manufacturers to understand workflows and collaboration points.
• Begin supporting document and change control processes ensuring they follow internal procedures and regulatory rules.

In 3 Months:

• Take charge of CAPA (Corrective and Preventive Actions) leading investigations identifying root causes and ensuring timely resolutions.
• Manage complaint handling conducting investigations and ensuring timely reporting when needed.
• Help organize and improve Flexs document library structure.
• Assist in preparing and conducting internal audits to meet quality standards and highlight areas for improvement.
• Provide quality training to teams helping them better understand regulatory needs and building a qualityfocused culture.

In 6 Months:

• Lead risk analysis efforts to improve product safety and compliance creating strong risk management documents in line with ISO 14971 standards.
• Improve quality system processes (like document control CAPA and complaint handling) to boost efficiency and compliance.
• Successfully support external audits or inspections ensuring Flex meets regulatory expectations.
• Introduce and implement ongoing improvements in quality systems to build a scalable and effective foundation for compliance and operations.

About Flex

The Flex Company was founded on the belief that people deserve innovative sustainable lifechanging period products. After years of disappointment and discomfort trying dozens of products Lauren Schulte Wang founded Flex to create bodysafe medical grade alternatives that outperform traditional period products. Flex Disc and Flex Cup generate 60 less waste and have the capacity of up to three super tampons all while maintaining the highest level of comfort through inventive engineering and rigorous testing.

Flex is sold at over 28000 stores across the US and is the #1 better for you period brand based on units sold. Committed to making its lifechanging products accessible to as many people possible Flex is available at Target CVS and Walgreens and at flexfits.

Flex is an equal opportunity employer. We recruit employ train compensate and promote regardless of race ethnicity religion sex gender age and other protected categories. From our hiring practices to the design of our flagship products we believe equity and diversity is critical to the ideas talent and processes that help us create the most positive impact for our customers and for each other. We encourage people of all backgrounds and identities to apply to be a team member here. Moreover Flex considers for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.

Flex collects personal information from candidates as part of the application and hiring process. California residents can view our CCPA Notice at Collection and Privacy Policy which serves as our Notice of Collection for applicants and employees under the CPRA.

We pay competitive salaries equity & benefits including (but not limited to) medical dental and vision health insurance 401k paid parental leave open PTO 401k and a $1000 annual learning credit.