Director, Quality Assurance jobs in United States
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Frida · 2 days ago

Director, Quality Assurance

Frida is a company dedicated to supporting parents through every stage of parenting. They are seeking a Director of Quality Assurance to lead their Operations team in ensuring that products meet and exceed quality standards, focusing on the development and implementation of quality management systems and compliance with regulations.

BabyFirst AidHealth CareManufacturingMedical Device

Responsibilities

QMS: Develop, Implement and continuously improve the Quality Management System (QMS) in accordance with ISO 13485, FDA regulations (21 CFR Part 820), and other applicable standards and regulations. Ensures process improvement activities remain in compliance
QC plans: Assist in developing sustainable quality control plans with detailed testing standards that can be implemented across all new product development projects, on ongoing productions and enforced by suppliers. Incorporate quality plans + inputs into design stage gates and facilitate understanding of testing and quality variables among designers, engineers, 3rd party inspectors, and suppliers
QC Checklists: Create, implement, and continuously improve quality control checklists tailored to specific products, processes, and regulatory requirements
Collaborates with warehouse, including 3PLs, to establish quality procedures for incoming inspection, nonconforming material, preservation of product, material and storage handling, and production/process controls
CS: Interface with Customer Service to rectify quality complaints & facilitate CAPA processes. Communicate quality issues, progress on CAPA actions, and quality improvements to all relevant stakeholders within the company
User needs: Work closely with the cross-functional teams to understand user needs rooted in consumer insights and internal design standards so they are reflected in quality control standards
Testing: Coordinate testing with suppliers and 3rd party labs to ensure product performance meets consumer expectations and internal quality standards
Equipment: Maintain in-house calibration log up to date with equipment used for in-house design verification activities
Revising specs: Devise and review specifications for new and legacy products as they relate to quality testing standards, integrate with compliance to ensure testing is performed
Audits: Prepare for and manage external audits and inspections from regulatory bodies and customers. Responsible for the internal quality audits program. Address findings and implement corrective actions
CAPA Management: Oversee the Corrective and Preventive Actions (CAPA) process to identify root causes of non-conformances and ensure timely and effective resolution
Process: Drive quality improvement processes to identify and address high return rates on products and/or underperformance (for example, low star ratings)
Supplier Quality Management: Evaluate and monitor suppliers to ensure they meet the company's quality standards. This includes conducting supplier audits and managing supplier non-conformances
Team Management: Lead, mentor, and develop the quality team to ensure alignment with company goals, regulatory requirements, and continuous improvement initiatives. Foster a culture of accountability, collaboration, and proactive problem-solving within the team
Provides subject matter expertise in quality engineering such as: risk management and risk assessments, design verification, equipment qualification, process validation, design transfer, configuration management, and change control
Training: Develop and implement training programs and ensure employees are kept up to date with current standard operating procedures (SOPs), regulatory requirements, and company policies
Other projects as assigned

Qualification

ISO 13485FDA regulationsQuality Management SystemSix Sigma Green BeltQuality Control PlansTesting ProceduresSupplier Quality ManagementStatistical SoftwareMaterial Management SoftwareProject ManagementVerbal Communication

Required

+ 8-10+ years' experience in consumer products (preferred), Quality, Compliance, or related fields
+ Has hands-on experience developing, implementing and upgrading a quality management system tailored to the company's business model Must have a full understanding of the relevant regulations and requirements and how best to infuse the company culture of the criticality of implementing policies competently and consistently
+ Understanding of testing methods and some regulatory compliance (UL/ETL , FDA, ROHS, Prop65, etc.)
+ Experience crafting quality plans that Include: DFMEA's, Control Plans, Testing procedures, and AQL's
+ A keen eye for detail and a results-driven approach
+ Can navigate fluidly from strategic to tactical work, has highly developed multi-tasking and prioritization skills, is results-oriented with a strong self-motivation to move quickly to address opportunities thoroughly, while meeting tight deadlines
+ Working knowledge of Microsoft Excel, Word, Access, Visio, and documentation control software (preferably Aras PLM), material management software, and statistical application software
+ Excellent verbal communication skills with ability to speak effectively with clients, vendors, management staff and employees of organization
+ Excellent project management skills to develop quality objectives, manage overall quality plans, corrective and preventative actions, process improvement, and auditing timelines

Preferred

+ Six Sigma Green Belt preferred
+ Experience working directly with material and component vendors/suppliers and commodities (PCBAs, metals, plastics, cables) is preferred

Benefits

Comprehensive medical, vision, and dental plans
Employer paid life insurance
Supplemental insurance options including Accident Insurance, Short-Term Disability and Long-Term Disability
FSA & HSA
401k matching up to 4% with immediate vesting.
Generous paid time off program including elective PTO days, federal holidays, sick/wellness days, and a birthday floater.
Flexible paid pregnancy and parental leave.
Weekly wellness programming designed to maximize personal time and minimize time spent investing in personal care outside of work hours. This includes a variety of programming such as in-office manicures & pedicures, blowouts, massages, and carwash services.
Dog friendly office - feel free to bring your best buddy with you to work!
Learning & development opportunities for professional and personal growth
Company-wide events & outings. Team engagement is at the center of our culture. This ranges from small department-specific teambuilding or informal outings to our annual Fam Jam family carnival that celebrates the people in your life who support you in bringing your best self to work each day. We also host an annual Day of Service to support our local Miami community, and provide a variety of volunteer opportunities throughout the year that support our mission to serve parents and children.
Exclusive employee product discounts.

Company

Frida

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Frida manufactures and sells baby care products, grooming kits, mom products, first-aid, postpartum recovery and delivery kits.

Funding

Current Stage
Growth Stage
Total Funding
unknown
2020-12-01Acquired
2016-01-01Private Equity

Leadership Team

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Eddie Echeverri
Senior Director of Sourcing - Durables
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Company data provided by crunchbase