Senior Manager, Quality Assurance

How You Will Make an Impact

Our partner is looking for a Sr. Manager of Quality Assurance to join our Operations team and take the lead in ensuring the company´s current and new products meet and exceed quality standards. The ideal candidate will have a working knowledge of quality standards, such as ISO 13485 and FDA regulations (21 CFR Part 820). The Manager of Quality Assurance will focus on establishing quality standards and metrics in support of the new product development pipeline, as well as legacy products.

• 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. Adress 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.
• 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.

What You Will Need

• 5 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.
• Six Sigma Green Belt preferred.
• Experience working directly with material and component vendors/suppliers and commodities (PCBAs, metals, plastics, cables) is preferred.
• 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.

Who You Will Work With