Apply on Employer Site

Merz Aesthetics · 1 month ago

Senior Validation Quality Engineer/Validation Quality Engineer-Medical Device Manufacturing

Racine, WI

Full-time

Onsite

Mid, Senior Level

2+ years exp

Merz Aesthetics is a leading global aesthetics business with a rich history in specialty healthcare. The Senior Validation Quality Engineer role involves providing validation, engineering, and technical support for manufacturing and distribution, ensuring compliance with quality standards and regulations while leading quality improvement initiatives.

BiotechnologyHealth Care

Comp. & Benefits

No H1B

Responsibilities

Oversee the operation of the Quality System process related to product, process, and/or test method Validation and Re-Validation

Oversee the Installation, Operational and Performance Qualification activities for equipment, product, or systems installed including those requiring computerized operation/interfacing

Coordinate other activities associated with installation and proper configuration of new equipment as directed

Provide assistance to the Manufacturers and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes

Review and approve internal operating procedures and specifications

Capture data associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the purpose of Quality Improvement and reporting

Provide leadership and direction and promote Quality Improvement Processes

Coordinate, and analyze databases associated with oversight of the Quality System and its reporting process

Provide quality engineering support for supplier changes and resolution of issues at suppliers

Identifies new quality improvement initiatives / projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies

Works with manufacturing and other functional groups on manufacturing regulatory compliance issue

Support training program by delivering assigned training tasks

Support with federal, state, and local regulatory officials during regulatory inspections

Support in internal and vendor quality system audits as applicable

Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices

Provides support to Quality Management personnel and perform other duties as assigned

Qualification

Validation EngineeringQuality System ManagementMedical Device RegulationsStatistical AnalysisNCR/CAPA ProcessesTechnical WritingMicrosoft OfficeManage PrioritiesProblem-SolvingCommunication Skills

Required

Bachelor's Degree Physical Science or Engineering, or equivalent experience

2+ years Minimum in Medical Device or Pharmaceutical Industry or similar experience

2+ years Minimum in a Quality Role

2+ years Minimum in a Validation Engineering Role

Bachelor's Degree Physical Science or Engineering, or equivalent experience

3-5 years Minimum in Medical Device or Pharmaceutical Industry or similar experience

3-5 years Minimum in a Quality Role

3-5 years Minimum in a Validation Engineering Role

Knowledge of quality requirements for medical device / pharmaceutical organization

Strong technical writing skills

Strong technical and general problem-solving skills required; experience with NCR/CAPA processes

Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software

Experience with Statistical Analysis of Data

Experience with statistical sampling requirements for 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

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 required

Preferred

Minimum 2 years working with electromechanical devices

ASQ Certification as a Quality Engineer or equivalent

Minimum 3 years working with electromechanical devices

ASQ Certification as a Quality Engineer

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

And more!

Company

Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence.

Founded in 1908

Raleigh, North Carolina, USA

1001-5000 employees