Senior Quality Manufacturing Engineer

americas-cookmedical; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Americas-Cook Medical in Bloomington, IN, seeks a Quality Engineer to act as the lead quality representative for select product lines in manufacturing. You will ensure compliance with FDA 21 CFR 820, ISO 13485, and other medical device regulations while coordinating with internal and external teams.

Responsibilities include supporting development transfers, implementing production controls, investigating non-conformances, performing root cause analysis, and driving CAPAs.

Qualifications

• Engineering degree and 5–8 years of experience in quality engineering.
• Knowledge of medical device regulations (ISO 13485, 21 CFR) and risk management (ISO 14971).
• Professional certification (e.g. ASQ, Six Sigma) preferred.
• Proficiency with statistical and quality improvement methods and tools.
• Proficiency with Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
• Strong organizational skills and attention to detail.

Responsibilities

• Lead quality representation for select product lines in manufacturing.
• Interface with internal and external groups on quality issues.
• Support product development and transfer to manufacturing.
• Develop and implement production controls (qualification, process capability, sampling, validation).
• Investigate non-conformances, perform root cause analysis, trend monitoring, and issue escalation.
• Plan, review, and approve change requests.
• Conduct risk assessments and develop risk documentation; support CAPAs.
• Lead audits (internal or third-party) as needed and drive continuous improvement.
• Collaborate across quality, engineering, production, clinical, and regulatory affairs.

Skills

Quality engineering

Regulatory knowledge

Risk management

Statistical methods

Continuous improvement

Attention to detail

Communication skills

Education

Engineering degree

ASQ / Six Sigma certification preferred

Tools

MS Office

Job description

Overview

The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing.

Responsibilities

• Perform work per external and internal quality standards.
• Interface with internal and external groups on quality-related issues.
• Support product development and transfer to manufacturing.
• Facilitate development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
• Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
• Plan, review, and approve change requests.
• Execute risk assessment as needed and facilitate development and completion of risk file documentation.
• Conduct risk-based decision making and effective resolution of issues.
• Lead or support CAPAs as necessary.
• May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
• Provide leadership in the understanding of medical device regulations and best practices.
• Manage conflict resolution as it relates to technical situations.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

• Engineer degree and 5-8 years of experience.
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971).
• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred.
• Proficiency in statistical, quality and continuous improvement methods and tools.
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.
• Strong organizational skills.
• Critical thinking and attention to detail required.