New Product Development QA Manager

About Us

SharkNinja is a global product design and technology company with a diversified portfolio of 5star rated lifestyle solutions that positively impact peoples lives in homes around the world. the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories driving significant growth and market share gains. Headquartered in Needham Massachusetts with more than 3300 associates the companys products are sold at key retailers online and offline and through distributors around the world.

Position Overview:

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 crossfunctional 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.

Position Purpose:

• 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 crossfunctional teams to assign mitigation plans for highrisk items identified from DFMEA including design changes design validation tests tolerance stackup analysis (T/S) and Finite Element Analysis (FEA).

• Oversee prototype and EB sample teardown checks to ensure adherence to Design for Manufacturing and VAVE principles and confirm that major improvement actions are closed.

• Participate in tolerance stackup analyses (T/S) and FEA result reviews.

• Communicate the project risk assessment report (compiled by the China NPD quality team) 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 Prototype2 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 and that process capability (e.g. CPK values) is sufficient.

• Collaborate with the injection tooling team for optical parts and largesize part mold flow reviews.

• Review the product online test protocol to ensure all key performance items are covered and test data is reliable.

• 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 crossfunctional 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/EUMDR.
• Monitor quality KPIs to achieve targets.
• Leverage data analytics for quality performance insights to support datadriven decisionmaking.
• 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 crossregional 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.

Key Performance Indicators:

• 99 line FPY with zero technical issues at the beginning of MP

Position Requirements/ Experience:

• 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.

• Indepth 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 crossfunctional teams in a fastpaced dynamic environment.

• Excellent verbal and written communication skills in English with strong interpersonal and crosscultural communication abilities and the ability to present ideas in a clear fluent and tothepoint manner.

• A collaborative team player with a strong desire to make a significant impact along with high confidence selfmotivation and a strong sense of responsibility and deliverability.

• Proactive optimistic and action/result oriented; capable of driving sustainable performance and positive change.

• Strong risk insight and decisionmaking capability using logic and insight to solve complex problems and create effective solutions.

• Ability to support global travel for short durations (e.g. to China Thailand Vietnam etc..