Senior Quality Engineer-EBD

Job Category: Quality Systems/Customer Satisfaction

Requisition Number: SENIO
004511

Location: Racine, WI 53401, USA

Showing 1 location

About Us
Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living.

Live your best life with Merz Aesthetics.

A Brief Overview
This position is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. This position supports a wide array of activities related to Change Control, NCR/CAPA, Quality Operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. The role evaluates the operation of Manufacturing and Quality activities in relation to compliance with Quality Standards and Regulations and recommends corrections or improvements.

Provides direct support to Quality personnel regarding operation of the department and Quality System. Supports other departmental activities as directed.

• Change Control:
  Review change requests and identify impact on product design and documentation. Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to manufacturing procedures, process, product/specifications, risk management files, etc. through the Change Control process. Support 3rd party supplier management activities such as reviewing 3rd party design control activities.
• Design Control:
  Documentation review for technical accuracy and compliance to procedures. Review Technical Writing and Documentation. Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
• Quality Initiatives:
  Provide quality engineering support for supplier changes and resolution of issues ntify new quality improvement initiatives/projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Work with manufacturing and other functional groups on manufacturing regulatory compliance issues. Support training program by delivering assigned training tasks.
• Support NCR and CAPA:
  Support/lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing data for quality improvement and reporting.
• Risk Management Support:
  Risk management activities including review and coordination of quality activities related to risk.
• Inspections:
  Support with federal, state, and local regulatory officials during regulatory inspections. Support in internal and vendor quality system audits as applicable.
• Adherence to regulations:
  Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.
• Other duties as assigned:
  Provides support to Quality Management personnel and performs other duties as assigned.

• Bachelor of Science (B.S.) Physical Science or Engineering, or equivalent experience.
• 6+ years experience in a regulated industry (medical device, pharma, biotech, or similar), including 3+ years in a Quality Engineering or Quality-focused role.
• Working knowledge of:
• ISO 13485
• FDA 21 CFR 820
• CAPA, NCRs, Deviations
• Change Control / Change Management
• Preferred Qualifications
• Quality Role.
• Experience with electromechanical or software-enabled medical devices strongly preferred.
• ASQ Certification as a Quality Engineer or equivalent.

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Strong technical writing skills.
• Ability to analyze product changes and identify their impact.
• Strong technical and general problem-solving skills; experience with NCR/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio;
  Adobe; and Quality System Management Software.
• Understanding of system software, firmware, and hardware integration.
• Familiarity with statistical sampling requirements for Design Verification and Process Validation.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Ability to manage multiple priorities and work with interruptions.
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when…