Overview
Manufacturing & Quality Engineer Jobs in Racine, Wisconsin, USA at Daniels Health
Role Overview
The Manufacturing & Quality Engineer plays a critical role in ensuring exceptional quality standards across supply chain and production processes. This role is focused on implementing advanced problem-solving methods, performing root cause analysis, and driving corrective and preventive actions (CAPAs) to resolve non-conformities effectively. It offers significant growth potential and the opportunity to work on various interesting projects beyond core responsibilities.
Who
are we looking for…
The ideal candidate possesses strong problem-solving and root cause analysis skills, attention to detail, and excellent communication skills. Experience working in a regulated manufacturing environment is required. Ability to independently drive issue and project closure with team support is essential. Knowledge of ISO 13485, 21 CFR Part 820 regulations, and cGMP standards is advantageous.
Key Responsibilities
Root Cause Analysis & Problem Solving
Perform thorough root cause analysis for quality-related issues using structured problem-solving tools.
Develop and implement CAPA plans, ensuring resolution effectiveness.
Identify process inefficiencies and recommend improvements to prevent recurrence.
Continuous Improvement Initiatives
Collaborate with cross-functional teams to identify and implement process, product, and system improvements.
Leverage data and trend analysis to identify areas for improvement.
Quality Control
Monitor and document non-conformities in products, processes, or services.
Lead investigations for complaints, ensuring stakeholder resolution.
Develop detection methods to proactively address new quality challenges.
Validation of Equipment/Processes
Assist in validating equipment and processes used in medical device production, ensuring compliance with standards.
Liaise with Suppliers
Act as the primary contact between the company and suppliers, fostering relationships and communication.
Address quality issues with suppliers and support continuous improvement initiatives.
Supplier Onsite Inspection & Audits
Support global engineering teams during onsite inspections at supplier facilities.
Support Production Team
Collaborate with the Production Manager to ensure seamless production and resolve quality challenges.
Skills and Qualifications
Experience with quality control tools, management systems, and validation procedures.
Desirable: experience in plastics manufacturing (injection molding, blow molding, etc.).
Excellent communication and interpersonal skills.
Strong attention to detail and problem-solving abilities.
Experience in medical devices and standards like ISO 13485, 21 CFR Part 820 preferred.
Relevant degree required.
Familiarity with QMS software for inspection records and non-conformities.
Character Competencies
Enthusiastic and motivated.
Responsible and compliant with quality and regulatory standards.
Organized, able to handle multiple tasks and meet deadlines.
Proactive in identifying issues and driving improvements.
Learn more about us and our mission!
Daniels Health & Sharpsmart is an equal opportunity employer. We prohibit discrimination and harassment and provide equal employment opportunities regardless of race, color, religion, sex, age, national origin, disability, veteran status, or other protected characteristics.
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Title: Manufacturing & Quality Engineer
Company: Daniels Health
Location: Racine, Wisconsin, USA
Category: Engineering (Quality Engineering, Process Engineer), Quality Assurance – QA/QC (Quality Engineering)
