New Product Development QA Manager

Shark Ninja Operating-posted 9 months ago
Full-time • Senior
Needham, MA
Professional, Scientific, and Technical Services
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The NPD Quality Manager is responsible for overseeing the complete quality management lifecycle of globally outsourced medical aesthetic devices. This role emphasizes leading risk analysis (including DFMEA/PFMEA) and optimizing the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDSAP, MDR, and other regulatory standards. Key duties include developing risk management documentation (per ISO 14971), conducting global supplier audits (including in China and Southeast Asia), managing process validation reviews, and driving cross-functional quality improvement initiatives through RCA and CAPA. The position also involves overseeing engineering change requests (ECR/ECN), monitoring key quality performance indicators, and developing process control guidelines.

  • Lead Design & Process Failure Mode and Effects Analysis (DFMEA/PFMEA).
  • Develop and maintain risk management documentation (ISO 14971), including risk analysis matrices and control plans.
  • Drive proactive quality planning by implementing Quality by Design principles and preventive improvement measures to mitigate future risks.
  • Review design specifications to identify New/Unique/Difference/Difficult (NUDD) items.
  • Coordinate with cross-functional teams to assign mitigation plans for high-risk items identified from DFMEA.
  • Oversee prototype and EB sample teardown checks to ensure adherence to Design for Manufacturing and VAVE principles.
  • Participate in tolerance stack-up analyses (T/S) and FEA result reviews.
  • Communicate the project risk assessment report to the US and UK teams.
  • Review the design qualification test plan (DQTP) at the product level to ensure all key KPIs are covered.
  • Generate the CTQ part list at the Prototype-2 stage.
  • Create the CTQ component reliability test plan per the component datasheet.
  • Review CTQ component drawings to ensure dimensions in T/S are defined correctly.
  • Collaborate with the injection tooling team for optical parts and large-size part mold flow reviews.
  • Review the product online test protocol to ensure all key performance items are covered.
  • Organize project and product lessons learned summits post mass production.
  • Drive VAVE activities like standardization and modular design concepts.
  • Conduct supplier qualification audits (including OEMs in China/Southeast Asia).
  • Define the CTQ process, identify CTQ parts, and specify associated suppliers.
  • Review supplier process validation documentation (IQ/OQ/PQ) to ensure manufacturing process robustness.
  • Support the Supplier Quality Management (SQM) team by auditing critical component suppliers globally.
  • Undertake international travel to China/Vietnam/Thailand for supplier quality evaluations.
  • Lead cross-functional quality issue resolution, driving Root Cause Analysis (RCA) and continuous improvement initiatives.
  • Participate in internal audits and support preparations for FDA/CE regulatory inspections.
  • Approve Engineering Change Requests (ECR) with impact assessments on quality and compliance.
  • Collaborate with the QMS team to optimize procedures aligned with 21 CFR Part 820 and ISO 13485/MDSAP/EU-MDR.
  • Monitor quality KPIs to achieve targets.
  • Leverage data analytics for quality performance insights to support data-driven decision-making.
  • Support the core quality team in driving design or process optimization through field return data analysis.
  • Collaborate closely with the Chinese team and Contract Manufacturers (CM) to coordinate cross-regional projects and drive quality improvements.
  • Work across global resources located in different time zones (China/UK/Canada/Vietnam/Thailand).
  • Build solid working relationships through effective communication with all stakeholders.
  • Minimum of a BS in Mechanical or a related engineering discipline.
  • At least 10+ years in medical device quality management, with a minimum of 3 years in global supplier management or leading multinational quality teams.
  • Has small home appliance or skincare cosmetic product design experience is a plus.
  • Extensive experience in risk management methodologies (DFMEA/PFMEA, CAPA, SPC) and data analytics.
  • Experience in Quality, Manufacturing, Development, and New Product Introduction is preferred.
  • In-depth understanding of regulatory requirements including FDA QSR, ISO 13485, MDR, and MDSAP.
  • Strong knowledge of ISO 13485, with a lead auditor certificate preferred.
  • Basic knowledge of plastic injection molding tooling.
  • Proficient in quality tools and methodologies such as FMEA, APQP, PPAP, Control Plans, 8D, and Root Cause Analysis (RCA).
  • Familiarity with statistical analysis software (e.g., Minitab, JMP) and advanced quality management systems.
  • Demonstrated experience as a natural leader of cross-functional teams in a fast-paced, dynamic environment.
  • Excellent verbal and written communication skills in English, with strong interpersonal and cross-cultural communication abilities.
  • A collaborative team player with a strong desire to make a significant impact.
  • Proactive, optimistic, and action/result oriented; capable of driving sustainable performance and positive change.
  • Strong risk insight and decision-making capability, using logic and insight to solve complex problems.
  • Ability to support global travel for short durations (e.g., to China, Thailand, Vietnam, etc.).
  • Experience in small home appliance or skincare cosmetic product design.
  • Competitive health insurance.
  • Retirement plans.
  • Paid time off.
  • Employee stock purchase options.
  • Wellness programs.
  • SharkNinja product discounts.
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