About Thinx

Thinx Inc., an innovative company that is disrupting the menstrual hygiene and incontinence product categories. The Thinx Inc. family of brands—Thinx, Thinx Teens, Thinx for All Leaks, and Thinx for All™—are on a mission to create a healthier world through sustainable solutions to menstruation and incontinence.

Our People

Our people live our values daily and they serve as our cultural cornerstones.

• Be Accountable
• Be Profitable
• Be Human
• Be Curious
• Be Ambassadors

Role Description

Thinx is seeking an exceptional contract Sr Quality Engineer to support our product quality function who will enable us to continue to fulfill our mission while remaining compliant with applicable laws and regulations

The Work You’ll Do:

• Support day to day quality activities including but not limited to non-conforming product, CAPA, change management, risk assessment, and design and development activities
• Author and support change requests, including procedure changes, product, process, and supplier changes
• Define data collection and analysis, and interpret data statistically to support various quality system requirements, utilize quality engineering tools as required
• Drive product containment decisions for non-conformances; author associated non-conforming product dispositions
• Review batch records for product release, provide recommendations for product disposition in ERP
• Communicate and escalate significant issues identified for released product; recommend process improvements, conduct root cause analysis and develop corrective and preventive action plans
• Provide guidance and expertise to internal and external teams on root cause analysis, process improvements, nonconformance investigation, risk management, supplier activities, and testing
• Quality representative for design verification / validation strategy and overall execution of QMS requirements; support various testing requirements at component and device level
• Maintain and support improvement of risk management files and adherence to design and development process / procedures
• Quality representative for special projects and ad hoc requests as needed
• Support audit readiness activities as required
• Support complaint investigations as required
• Support quality deliverables for EU MDR strategy as required
• Effectively navigate the complexities of various industry and government regulations to include FDA QSR 21 CFR 820, Canadian Medical Device Regulations (CMDR), EU Medical Device Regulations (EU MDR), and ISO 13485

This contract role is a highly cross-functional and dynamic role for the Quality and Compliance team and reports directly to the Sr Director of Quality & Compliance

We’re Excited About You Because…

• You have demonstrated foundational quality management competence in FDA regulated quality system, with understanding and experience in FDA QSR, cGMP, ISO 13485, ISO 14791, and EU MDR
• You’ve managed high profile investigations related to product and process failures, and are able to drive to root cause and effective actions
• You have a knack for simplifying complex problems and finding effective solutions
• You are able to work independently to develop solutions to various quality problems, that maintain alignment with organizational objectives
• You have a strong desire for “Right First Time”, and can build quality into processes, support risk management strategies, and have a keen sense for identifying continuous improvement efforts
• You have a clear understanding of risk-based approaches within the quality system and are able to make recommendations for mitigating high risk areas

Qualifications

• Bachelor's Degree required, engineering or scientific / technical degree preferred
• 5+ years of work experience in quality engineering roles
• Certified Lead Auditor in medical device preferred
• DMAIC/ Lean Six Sigma experience, Green or Black Belt certification preferred
• Exceptional communication skills, both internally and externally facing
• Ability to interface with internal customers, suppliers and external regulatory agencies

Our Compensation Philosophy

At Thinx, our compensation philosophy is driven by the goal of attracting, developing, and retaining the best people to further our mission, vision, and business goals. Compensation is influenced by a wide array of factors including and not limited to skill set, level of experience, and specific location. For New York City the rate for this position is $70 per hour. Candidates being considered for work in other locations will be subject to the base salary range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate’s offer letter. Base annual salary does not include other forms of compensation or benefits that may be available.

Our Commitment to Diversity and Inclusion

At Thinx, we are passionate and committed to curating a diverse, equitable, and inclusive company culture as well as a product line that is reflective of our market and consistent with our goals for growth. We believe that every person at Thinx and every person that wears our products is valuable to the company’s success.