What are the responsibilities and job description for the Quality Engineer II position at Medical Engineering Consultants (MEC)?
Job 2755 - Mid-Level Quality Engineer - Contract located near Dallas, Texas
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.
Onsite
Position Summary
Our Client is seeking a Mid-Level Quality Engineer to support the manufacturing and quality operations of a regulated medical device production environment focused on sterile, single-use disposable products. This position is responsible for ensuring quality standards are established, maintained, and continuously improved throughout product realization and manufacturing processes.
The ideal candidate will have hands-on experience in quality engineering, process validation, root cause investigations, CAPA management, and continuous improvement initiatives within a highly regulated industry.
This role is an onsite position requiring close collaboration with Quality, Manufacturing, Engineering, and Operations teams to ensure compliance with applicable regulatory and quality requirements.
Essential Responsibilities
Responsibilities may include, but are not limited to:
Required Qualifications
Specialist Career Stream
This position functions as an individual contributor with responsibility within a professional quality engineering discipline.
This position will manage and deliver assigned projects while collaborating with internal stakeholders to achieve desired outcomes.
Autonomy
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.
Onsite
Position Summary
Our Client is seeking a Mid-Level Quality Engineer to support the manufacturing and quality operations of a regulated medical device production environment focused on sterile, single-use disposable products. This position is responsible for ensuring quality standards are established, maintained, and continuously improved throughout product realization and manufacturing processes.
The ideal candidate will have hands-on experience in quality engineering, process validation, root cause investigations, CAPA management, and continuous improvement initiatives within a highly regulated industry.
This role is an onsite position requiring close collaboration with Quality, Manufacturing, Engineering, and Operations teams to ensure compliance with applicable regulatory and quality requirements.
Essential Responsibilities
Responsibilities may include, but are not limited to:
- Develop, modify, implement, and maintain quality standards, procedures, and protocols for manufacturing processes and products.
- Partner with Engineering and Manufacturing teams to ensure quality requirements are incorporated into production processes.
- Lead and support investigations involving nonconformances, product quality issues, customer complaints, and manufacturing deviations.
- Conduct root cause analysis and implement effective corrective and preventive actions (CAPA).
- Support process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop, execute, and review test method validations and verification activities.
- Perform statistical analysis and trend analysis to evaluate process performance and product quality.
- Design and implement inspection methodologies, sampling plans, and quality control processes.
- Evaluate manufacturing processes and recommend improvements to increase quality, reliability, and efficiency.
- Ensure quality documentation is complete, accurate, and compliant with applicable regulatory and quality system requirements.
- Support audits, inspections, and regulatory readiness activities.
- Participate in continuous improvement initiatives utilizing Lean, Six Sigma, and other problem-solving methodologies.
- Collaborate with cross-functional teams to achieve project milestones and quality objectives.
- Provide guidance and mentorship to junior engineers and quality professionals when appropriate.
Required Qualifications
- Bachelor's Degree in Engineering, Quality, Science, or related technical discipline.
- Minimum of 2 years of relevant Quality Engineering experience.
- Experience working in a regulated manufacturing environment required.
- Experience supporting quality systems, investigations, and validation activities.
- Technical Skills
- Problem Solving, Root Cause Investigation, and CAPA Management
- Process Validation, including Test Method Validation
- Six Sigma methodologies and continuous improvement tools
- Working knowledge of quality engineering principles and practices.
- Understanding of quality systems and regulatory compliance requirements.
- Experience analyzing data and using statistical techniques to support decision-making.
- Strong organizational skills and attention to detail.
- Effective verbal, written, and technical communication skills.
- Ability to work independently with general supervision on moderately complex assignments.
- Strong collaboration and cross-functional teamwork skills.
- Experience within the Medical Device industry or another highly regulated industry.
- Experience with Lean Manufacturing and Lean Six Sigma methodologies.
- Knowledge of statistical analysis tools and process capability concepts.
- Experience with sterilized products and disposable medical devices.
- ASQ Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certification.
- Experience supporting manufacturing quality improvements and process optimization projects.
Specialist Career Stream
This position functions as an individual contributor with responsibility within a professional quality engineering discipline.
This position will manage and deliver assigned projects while collaborating with internal stakeholders to achieve desired outcomes.
Autonomy
- Works independently with general supervision.
- Manages moderately complex projects and assignments.
- Supports achievement of project milestones and departmental objectives.
- Contributes to cross-functional initiatives and continuous improvement efforts.
- Identifies quality issues and recommends process improvements.
- Applies technical expertise to improve systems, procedures, and operational effectiveness.
- Regularly communicates with internal stakeholders to provide project updates, resolve issues, and support informed decision-making.
- May provide guidance and mentoring to entry-level engineers and support staff.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.