Senior Quality Engineer (Project Management)

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

The Senior Quality Engineer is responsible for providing support of R&D Quality activities as related to Medical Devices including the completion of day-to-day R&D Quality project activities. Additionally, this position will operate as a liaison among the various R&D functions and the Quality Operations departments.

What you will do

• R&D Project Teams:
  • Responsible for supporting Medical Devices Project Teams and attending meeting in a Quality consultancy capacity
  • Support document reviews and regulatory submissions
  • Effectively manage project timelines as defined by department, project team, and corporate objectives
• Risk Management:
  • Facilitate and provide input to risk management activities throughout all stages of the device development process
  • Manage the risk management plan, risk file and risk report for assigned projects
• Human Factors Engineering:
  • Facilitate and provide input to human factors/usability activities throughout all stages of the device development process
  • Manage the human factors engineering/usability plan, Use/misuse error analysis, usability task analysis, facilitate formative and validation protocols and report
• Design & Development:
  • Facilitate and provide input to Medical Device manufacturing and Design & Development activities throughout all stages of the device development process (i.e. general Product Development / Design Control customer input, specification development, verification and validation testing, manufacturing transfer, risk assessment, usability, design change control).
  • Provide input and review Design & Development documentation for assigned projects
• Audits/Inspections:
  • Support R&D related audits, both internal and external
  • Support R&D vendors/suppliers qualifications
  • Support all Merz regulatory authority inspections and certification body audits, as applicable
• General R&D Support:
  • Lead NCR efforts for the R&D area
  • Support R&D related activities including but not limited to SOP creation and maintenance, NCRs, DCNs, CAPAs, deviations, change requests, archival, corporate, and departmental initiatives
• R&D Quality Improvements:
  • Facilitate and support harmonization initiatives within the R&D group
  • Facilitate and support projects to improve R&D compliance and operational efficiencies
• Quality Intelligence:
  • Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant as related to Medical Devices
  • Provide updates to R&D staff, as applicable
• Further Tasks:
  • Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate
  • Provide support to other R&D staff as needed and perform duties and assignments as required
• Other duties as assigned:
  • Additional duties as needed to support the quality department, business and overall company objectives

Minimum Requirements:

• Bachelor of Science (B.S.) In life sciences or engineering field
• 5+ years Minimum 4-6 years relevant Quality/Compliance and medical device development experience
• Working knowledge of ISO13485, 21CFR820, EUMDR and/or MDSAP
• Exposure to Medical Devices class II and/or III products

Preferred Qualifications:

• Master's Degree In Engineer field
• ASQ Six Sigma Green Belt; ASQ Certified Quality Auditor
• Supplier Qualification experience
• ISO13485 and/or MDSAP Lead Auditor certification

Technical & Functional Skills:

• Exposure to electromechanical products and/or injectable implants
• Knowledge of regulatory requirements and standards for a medical device product (i.e., 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines.)
• Proficient in MS Office and Master Control
• Demonstrated organizational skills, ability to independently prioritize work and be detail oriented
• Strong verbal and written communication skills
• Ability to work in a global, matrix environment
• Ability to effectively multitask and manage multiple projects

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Quality Systems/Customer Satisfaction