Business Quality Manager (Onsite in Hauppauge, New York)

WSAudiology is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

Our portfolio of technologies spans the full spectrum of hearing care, from distinct hearing brands and digital platforms to managed care, hearing centers and diagnostics locations.

Essential Responsibilities

Quality Management System/RA/Compliance

• General: Ensure regulatory compliance for all USA affiliates. Ensure compliance to global applicable policies.
• Document Control: Implement and lead local Document Control including Implementation of local change management process (tracking, monitoring, reminding, escalation) of local Change Requests; ensuring that local quality relevant records are archived and kept up to date and lead maintenance of local QMS system section
• Training: Roll out quality relevant trainings to the affiliate, maintain a local training matrix, train employees on quality relevant topics, administrate the global eLearning Platform for USA.
• CAPA: Work on Corrective and Preventive Actions and perform global CAPA checks. Monitor, follow-up and escalate CAPAs.
• Audit support: host local internal audits and support and host customer or authority inspections
  
  

Quality Operations

• Ensure implementation processes supporting local manufacturing/sales/distribution operations, to ensure compliance to regulatory requirements e.g. ISO 13485 certification and CFR 21 QSR FDA part 820.
• Provide support and guidance on key OPS topics like local complaint investigation, Change control, NPI/Design Transfer, Process Control & Validation, Incoming Inspection and local Supplier Management.
  
  

QA Customer Service and Sales

• Support customer service towards quality relevant topics, e.g. complaint handling.
• Monitor customer feedback and ensure all potential complaints are identified.
  
  

Data Analysis

• Prepare and moderate yearly management review.
• Lead monthly data analysis meeting, where quality relevant KPIs are tracked. Define actions, if KPIs are not met and own follow-up.
  
  

Leadership

• Lead of 2-3 Business Quality Headcount in USA
• Ensure proper split of activities.
• Plan and execute required team development.
  
  

Qualifications

• Bachelor’s degree in engineering or other related natural science/business discipline combined with relevant experience. Master’s degree in business management or engineering preferred
• Experience working for medical device companies/manufacturers & experience with ISO 13485 and MDSAP
• Knowledge of US FDA QMSR/QSR
• Must be available for 25% travel (travel will be to Canada, USA and Tijuana, Mexico)
• Strong leadership and communication skills.
• Ability to work independently and as part of a team.
• Excellent problem-solving and decision-making skills.
• Strong organizational and time-management skills.
• Ability to manage daily activities independently and managing several stakeholders in parallel.
  
  

The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.