Quality Project Lead/ Beauty - Intense Pulsed Light

Key Areas of Responsibilities:

• Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
• Performs independent technical assessment on product quality performance and post-market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required.
• Supports stakeholders during the execution of quality system- and product audits and inspections
• Independently produces and completes Quality quality engineering documents.
• Responsible for performing timely, quality engineering tasks like assessing quality plans, assessing product designs and reviewing test and other performance data, analyses market feedback, lead root cause analysis and quality problem solving.

Quality Project lead is collaborating with the following main stakeholders with regards to the KAR'S: - R&D Engineers - Post Market Surveillance investigators - Risk Management engineers - Product Support Engineers - Regulatory Affairs Specialists - Quality Manufacturing Engineers - Product Industrialization Engineers - Supplier Quality Engineers - Reliability Engineers

We are looking for

• Bachelor's degree with 5+ years of related experience or a master's degree with 3+ years of related experience. 
• 3+ years of related experience in a medical device or other regulated industry.
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001. 
• Preferably experience in a medical device industry. Working knowledge of appropriate global regulations, requirements, and standards. 
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project 
• Communicate globally, across teams and programs, from senior executives to administrative support personnel. 
• Both detail oriented and able to see big picture 
• Quality mindset and experience with Q tools like statistical engineering, Design for Six Sigma and/or Reliability Engineering.
• Proactive and supportive attitude towards the product development team, being a role model for the Quality function in the project team.
• Understanding of how product development projects are managed and how Quality plays a role in this;
• Required Competencies:
  - Quality Management - Risk Management - Design Controls and change Management - Quality Assurance - Quality Engineering - Verification/ Validation and Design Transfer

Product Quality Methods and Tools

• Requirement Development methods; VPC - IPM ? CTQ development process
• Field Call Rate target setting, prediction & Follow-up, CREX methods
• Basic statistics; Hypothesis testing; GR&R, Capability analysis. Cpk's / Z-scores
• Critical To Quality (CTQ) flow-down and Capability flow-up
• Risk analysis: several types of Failure Mode & Effect Analysis, can act as FMEA Coach. 
• Transfer function principles; Design of Experiments, Sample Sizes, Confidence Levels
• Robust Design: Lifetime testing, Reliability Testing, basic Weibull statistics MTBF, FCR prediction
• HALT: Highly Accelerated Life Testing, test to Failure 
• Supplier Quality methods, APQP
• Compliance, safety, and regulatory regulations 
• Sustainability requirements, 
  Preference:
  -   Experienced in Innovation and Development Quality
  -   Experienced in handling:
  o    Product Life cycle management 
  o   Change Management
  o   Product Development, Launch and Maintenance