Quality Engineer (Architecture)
About the Company:
Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.
Key Responsibilities:
Change Control
- Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to operating procedures, process, product specifications, risk management files, etc. through the Change Control process.
- Support validation and qualification activities (IQ-OQ-PQ) of equipment and process updates through the Change Control Process.
Design Control
- Support operations, sustaining engineering, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
- Originate and/or review internal operating procedures and specifications through the Document Change process.
Risk Management
- Support Risk Management activities including review and coordination of quality activities related to risk.
Quality Initiatives
- Identify 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.
- Leads process improvement initiatives for the Quality Department.
Support NCR and CAPA
- Support / lead corrective/preventive actions, including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, SCARs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
Adherence to Regulations
- Ensures adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.
Inspections
- Support with federal, state, and local regulatory officials during regulatory inspections.
- Support in internal and vendor quality system audits as applicable.
Other duties as assigned.
- Provides support to Quality Management personnel and perform other duties as assigned.
Education:
- BS in Physical Science or Engineering, or equivalent experience – Required.
Experience:
- 2 years in Medical Device or Pharmaceutical industry or similar experience – Required
- 2 years in a quality role - Preferred
- ASQ Certification as a Quality Engineer or equivalent – Preferred
- Six Sigma Green Belt – Preferred
Knowledge, Skills and Abilities:
- Knowledge of regulatory requirements for medical device/pharmaceutical organization.
- Strong technical and general problem-solving skills required; experience with NCR/CAPA processes.
- Computer skills in Microsoft Word, Excel, PowerPoint, Visio and Access; Adobe; SAP, and Quality System Management Software.
- Familiar with ISO 13485 Quality System Standards, ISO 14971, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
- Lean Six Sigma methodology.
- 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.
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!
Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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For further information, please review the Know Your Rights notice from the Department of Labor.
Quality Assurance Engineering
