Quality Engineer Associate I

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.

About the Role

This position supports a wide array of activities related to: Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Change Control, Product Surveillance, Design Control, New Markets, and Risk Management. You will support the operation of Manufacturing and Quality activities in relation to compliance with Quality Standards and Regulations, recommend corrections or improvements, provide direct support to Quality personnel, and assist with other departmental activities as directed.

Responsibilities

• NCR and CAPA activities: Execute Investigations, Root Cause Analysis, Correction, Corrective and Preventive Action activities in accordance with the Merz North America Quality System for NCRs and CAPAs, including capturing data and investigations associated with product deviations, product nonconformances, CAPAs, scrap, and rework. Analyze data for Quality Improvement and reporting.
• Change Control activities: Originate, review, and approve internal operating procedures and specifications through the Document Change process.
• Product Surveillance: Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints. Analyze data for Quality Improvement and reporting.
• New Markets activities: Support New Markets activities, including management of new markets samples process, coordination between new markets group in Germany and WI Tech Ops to manufacture samples, and filing of applicable new markets documentation in the Design History File (DHF).
• Risk Management activities: Support Risk Management activities, including data preparation for annual product risk file review, review of internal documents (IFU, CER, etc.) for annual product risk file review, management and preparation of event-based reviews, and review and coordination of quality activities related to pFMEA risk matrices.
• Internal and Vendor Audit Functions: Support Internal and Vendor Audit Functions as needed.
• R&D Support: Provide assistance, as needed, to the R&D department in the development and validation of new products.
• Process improvement initiatives: Coordinate process improvement initiatives for the Quality Department.
• Adherence to regulations: Assist with adherence to all Federal, State, and Local Regulations controlling the manufacture of medical devices.
• Other duties as assigned: Provide support to Quality Management personnel and perform other duties as assigned.

Requirements

• Bachelor's Degree or equivalent experience.

Qualifications

• Bachelor's Degree (BS/BA) in Engineering or Physical Science (preferred).
• GLP/GMP experience.
• Medical Device experience.
• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, and/or Validation.
• Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Management Systems (LIMS), and Quality Management software is highly preferred.
• Knowledge of quality systems, quality techniques, current regulatory requirements, and technical issues resolution.
• Proficiency with all equipment in the lab, as well as equipment preventative maintenance and method/process troubleshooting.
• Familiarity with general laboratory and incoming supply inspection testing.
• Computer skills including word processing, spreadsheet programs, databases, and statistical analysis.
• Ability to prepare testing protocols and reports, operating documents, and procedures.
• Ability to work with little or no supervision and make effective decisions.

Benefits

• Comprehensive Medical, Dental, and Vision plans.
• 20 days of Paid Time Off.
• 15 paid holidays.
• Paid Sick Leave.
• Paid Parental Leave.
• 401(k).
• Employee bonuses.
• Benefits and PTO start the date you're hired with no waiting period.

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.