Job Description

Title: Quality Analyst SR (Quality Engineer)

Location: Sturtevant, WI

Duration: 6-month contract, possibility of Extension

100% on-site (no remote candidates)

A Brief Overview

This position is responsible for providing Quality Engineering and Technical Support for Operations, Sustaining Engineering, R&D, and New Product Introductions. This position would include supporting a wide array of activities related to Change Control, Client/CAPA, Quality Operations, Design Control, New Product Development, Risk Management and Post Market Surveillance. This position would evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are needed. Provide direct support to Quality personnel regarding operation of the department and Quality System. Provide support to other departmental activities as directed.

What You Will Do

• Change Control: Review change requests and identify impact on product design and documentation Support Change Control Activities (Operations, Engineering, Design, etc.). Support updates to manufacturing procedures, process, product / specifications, risk management files, etc. through the Change Control process. Support 3rd party supplier management activities such as review 3rd party design control activities.
• Design Control/Documentation : Review documentation for technical accuracy and compliance to procedures Review Technical Writing and Documentation Support operations, sustaining engineer, R&D and NPI departments in the development, verification and validation of product changes and introduction of new products.
• Quality initiatives : 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 Client and CAPA: Support / lead corrective/preventive actions and product non-conformances including capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.
• Risk Management: Support Risk Management activities including review and coordination of quality activities related to risk.
• Inspections: Support with federal, state, and local regulatory officials during regulatory inspections Support in internal and vendor quality system audits as applicable.
• Adherence to regulations : Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of Electromechanical Devices (EMD) and non-EMD medical devices.
• Other duties as assigned: Provides support to Quality Management personnel and perform other duties as assigned.

Minimum Requirements:

• Bachelor of Science (B.S.) Physical Science or Engineering, or equivalent experience.
• 3-5 years Quality Engineering Role.
• 6-7 years Medical Device or Pharmaceutical Industry or similar experience.

Preferred Qualifications:

• Working with electromechanical devices.
• ASQ Certification as a Quality Engineer or equivalent.

Technical & Functional Skills

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Strong technical writing skills.
• Ability to analyze product changes and identify their impact.
• Strong technical and general problem-solving skills required; experience with Client/CAPA processes.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.
• Understanding of system software, firmware, and hardware integration.
• Familiarity with statistical sampling requirements for Design Verification and 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.

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