Summary:
We are seeking a Quality Engineer to join our team and support a client within the medical device industry. The Quality Engineer will provide quality engineering support for manufacturing operations, with a strong focus on validation activities, quality compliance, problem solving, and continuous improvement. This role will collaborate closely with Manufacturing, Engineering, Quality, and other cross-functional teams to ensure products and processes consistently meet established quality standards, specifications, and applicable regulatory requirements.
Scope of Work / Key Responsibilities
- Provide Quality Engineering support for manufacturing processes, products, equipment, and validation activities.
- Develop, review, execute, and approve validation and qualification documentation, including protocols, test plans, reports, and supporting documentation.
- Collaborate with Manufacturing and Engineering teams to establish and maintain appropriate quality standards and acceptance criteria.
- Support process and equipment validation, including IQ, OQ, PQ, and other qualification activities as applicable.
- Review and analyze manufacturing and quality data to identify trends, risks, and opportunities for improvement.
- Lead or support investigations related to nonconformances, deviations, manufacturing issues, and product quality concerns.
- Perform and support root cause analysis and the development and implementation of effective corrective and preventive actions (CAPAs).
- Support change control activities and assess proposed changes for potential impact on product quality, validated processes, and regulatory compliance.
- Develop, review, and maintain quality documentation, procedures, specifications, inspection methods, and engineering records.
- Apply statistical methods and quality engineering tools to evaluate product and process performance.
- Support the development and implementation of inspection, testing, and acceptance methods for products and manufacturing processes.
- Ensure corrective actions and process improvements meet established quality and reliability requirements.
- Partner with cross-functional teams to identify and implement improvements that enhance product quality, process capability, compliance, and manufacturing performance.
- Ensure activities and documentation comply with applicable GMP, Quality System, and medical device regulatory requirements.
- Support internal and external audits, inspections, and other quality system activities as required.
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Required Qualifications:
- Bachelor’s degree in Engineering or a related technical discipline.
- Previous Quality Engineering, Validation, Manufacturing Engineering, or related experience within a regulated environment.
- Experience with validation and/or qualification activities.
- Understanding of quality systems and documentation requirements within regulated manufacturing.
- Strong analytical, troubleshooting, and problem-solving skills.
- Ability to perform root cause analysis and support effective corrective actions.
- Strong attention to detail and documentation practices.
- Excellent communication and teamwork skills with the ability to collaborate effectively across Engineering, Manufacturing, Quality, and Operations.
Preferred Qualifications:
- Previous experience within the medical device industry.
- Hands-on experience with process validation, equipment qualification, IQ/OQ/PQ, validation protocols, and reports.
- Experience with CAPA, nonconformance investigations, deviations, and change controls.
- Knowledge of statistical analysis, SPC, process capability, risk management, and other Quality Engineering tools.
- Familiarity with FDA Quality System requirements, ISO 13485, GMP, and applicable medical device regulations.
- Experience supporting manufacturing operations in a regulated production environment.
Top Candidate Priorities:
1. Validation Experience
Hands-on experience supporting validation and qualification activities, preferably within medical device or another highly regulated manufacturing environment.
2. Problem Solving
Strong analytical and troubleshooting capabilities with experience conducting root cause investigations and implementing effective corrective actions.
3. Cross-Functional Teamwork
Demonstrated ability to collaborate effectively with Quality, Manufacturing, Engineering, Operations, and other stakeholders to resolve issues and maintain compliance.
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Job Details:
Contract Duration: 1+ years
Location: On Site (South East, Puerto Rico)
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Why Apply?
This is a unique opportunity to work on a high-impact project in the pharmaceutical sector with a respected and growing firm. At SoltechPR, we value our people and are committed to offering meaningful work, professional development, and a supportive team environment. If you’re ready to bring your expertise to a major construction initiative in the regulated industry, we’d love to hear from you.
Apply today and become part of something impactful!