What are the responsibilities and job description for the Senior Quality Engineer position at Merz Aesthetics?
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
