Sr. Quality Engineer (Clean room, sterilization, disposables)

Colonial Group; Allen (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Colonial Group is seeking a seasoned Quality Engineer to maintain and improve the quality management system across design, development, and manufacturing of components and finished products in Allen, TX. You will lead CAPA initiatives, perform root-cause analyses, and drive corrective actions to eliminate quality problems.

You will audit suppliers, manage supplier metrics, review ECOs and validation reports, and enable strong QMS compliance with FDA/ISO standards.

Qualifications

• Bachelor of Science in a technical field and 5 years in quality engineering in regulated industry.
• Experience in medical device or pharmaceutical manufacturing preferred.
• Strong knowledge of FDA, ISO 13485, ISO 9001, ISO 14971.

Responsibilities

• Maintain and improve the quality management system.
• Lead CAPA activities and root-cause investigations.
• Conduct supplier audits and manage supplier metrics.
• Oversee product testing, validation, and QMS compliance.
• Support internal and external audits; review ECOs and validation reports.
• Mentor QA technicians and production staff.

Skills

Quality engineering

CAPA leadership

Risk assessment

Statistical analysis

Auditing

Supplier quality

QMS

Data analysis

Education

Bachelor of Science in engineering/science

ASQ CQE/CQA

Tools

Minitab

MS Office

Job description

Summary:

Responsible for maintaining and improving the quality management system. Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products. Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements corrective actions to eliminate quality problems. Leads teams focused on CAPA. Leads Risk Assessment activities related to new and existing products. Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier corrective action plans. Develops various product tests and conducts data analysis. Manages engineering projects. Supports the internal and external audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.

General Duties and Responsibilities:

• Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
• Hands-on experience in developing Quality Systems, Processes and Procedures.
• Experience in Product Lifecycle Management and Product Data Management.
• Demonstrated capability in Quality Concepts, Quality Tools, Statistical Analysis and Metrics reporting.
• Provide technical support for incoming inspection and lot release testing activities.
• Analyze Product Structure, Product Data and manufacturing transfer readiness. Initiate and implement improvement actions for product and process quality improvements.
• Provide support and leadership to Product Improvement Teams as lead Quality Engineer.
• Lead defect and repair reduction programs to drive down Cost of Quality (COQ) metrics. Conduct internal and external audits for improving performance and quality metrics.
• Manage customer complaint and NCMR investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint. Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.
• Manage engineering projects focused on improving product quality and QMS compliance.
• Generate, review and approve ECOs and Validation Reports.
• Provide oversight to the Supplier Quality program by evaluating potential suppliers, managing supplier corrective actions, performing supplier audits, and evaluating quality metrics.
• Support the Internal Audit program by auditing, identifying and correcting deficiencies, creating reports, and conducting verifying effectiveness of corrective actions.
• Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects. Review and approve all studies, qualifications, and engineering change orders associated with the project.
• Develop and revise quality system procedures (SOPs and WIs).
• Develop/ write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
• Develop and maintain risk management files and quality control plans for components, devices and processes.
• Provide training and/or technical guidance to QA Technicians and production staff as required.
• Provide expertise in statistical analyses and interpretations for investigations, specification-setting activities, and test protocols.
• Participate in audits with FDA, ISO, MDD, and other regulatory agencies.
• Lead major quality projects that result in CPAR files.
• Use effective problem solving techniques to support successful completion of job duties.
• Strive to constantly innovate and implement improvements for improved methods for testing components.
• Work independently without supervision and have the ability to mentor junior quality associates.

Qualifications:

• Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience.
• A minimum of 5 years of experience in a quality engineering role in regulated industry experience such as medical device or pharmaceutical is required. A minimum of 2 years’ experience in the medical device manufacturing industry is preferred.
• Working knowledge of analog and digital circuits, embedded software and firmware, technical knowledge of hardware such as sensors, motors, valves.
• Familiarity of electronics components, electrical PCB’s, thermal systems, software testing and validations, unit and black box testing related to safety, performance and compliance
• Combined experience with electronics, PCBA (circuit boards), telecom or consumer or medical device electronics products in a product engineering quality engineering role.
• Experience with customer facing functions such as sales support, customer support, and field deployment.
• Strong unbiased advocate of compliance.
• Expertise in FDA Quality System Regulation, ISO13485, MDD, ISO 9001, and ISO 14971, including experience auditing to these requirements. Experience with all facets of IEC 60601 necessary
• Must possess technical writing, project management and fundamental problem-solving skills.
• Strong experience using MS Office, data management software and statistical analysis software programs (Minitab preferred).
• Demonstrated experience in a variety of process technologies and manufacturing environments, problem-solving methodologies, and statistics.
• ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.
• Certified Lead Auditor and Six Sigma Green or Black Belt preferred.
• Previous experience performing laboratory and/or mechanical/electrical testing required.
• Ability to manage multiple projects with conflicting priorities.
• Excellent writing and communication skills.
• Ability to travel 10% of the time.