Process Engineer - Theragenics

The Process Engineer is essential to ensuring the seamless integration of manufacturing processes with quality management systems, driving operational efficiency, product excellence, and regulatory compliance. This role combines process engineering expertise to optimize production workflows and resolve technical challenges with quality engineering responsibilities, including maintaining product quality, managing non-conformances, and supporting continuous improvement efforts.

This individual is responsible for supporting the development and implementation of robust procedures, track key performance indicators, and ensure alignment with industry standards. A successful Process Engineer will bring strong problem-solving skills, a data-driven mindset, and a proactive approach to identifying and implementing process improvements.
 RESPONSIBILITIES

• Develop, implement, and maintain quality management systems (QMS) to support continuous improvement across product lines and processes.
• Conduct root cause analysis (RCA) for non-conformances, corrective actions (CAPAs), and audit findings.
• Collaborate with cross-functional teams to resolve quality issues and ensure timely implementation of preventive measures.
• Ensure compliance with industry standards (e.g., ISO 13485, FDA 21 CFR Part 820, MDR) through periodic internal audits and monitoring of quality documentation.
• Perform statistical process control (SPC), process capability studies (Cp/Cpk), and gage R&R to maintain product consistency.
• Establish and monitor key performance indicators (KPIs) related to product quality and process effectiveness.
• Oversee product inspection and testing activities.
• Develop validation protocols, coordinate protocol execution and generate final reports.  Includes process & equipment validation as well as software verification. 
• Participate in evaluation of current processes and develop options for changes to ensure continuous efficient operations in manufacturing.
• Develop and participate in implementation of effective preventative and predictive maintenance processes to maximize equipment operations.
• Assume active role in the selection and certification of strategic suppliers.
• Conducting research and data analysis to support initiatives for optimizing the supply chain.
• Collaborating with cross-functional teams to streamline logistics, transportation, and distribution processes.

REQUIREMENTS

EDUCATION: 

• Bachelor’s degree in engineering, Life Sciences, or a related technical field (required).
• Advanced degree (preferred) or equivalent experience in relevant disciplines.

EXPERIENCE:

• Minimum of 1-3 years of experience in process or quality engineering, preferably within the medical device industry.
• Demonstrated experience in developing and optimizing manufacturing processes to ensure efficiency, quality, and regulatory compliance.
• Strong background in managing processes to drive continuous improvement.
• Hands-on experience with validation activities, including protocol development and execution.
• Familiarity with product design controls and risk management processes throughout the product lifecycle.

POSITION SKILLS:

• In-depth knowledge of medical device quality system regulations, including ISO 13485 and 21 CFR 820.
• Exceptional communication skills, both written and verbal, with the ability to convey technical information clearly.
• Strong interpersonal abilities to collaborate effectively across cross-functional teams.
• Proven ability to independently develop, execute, and document validation protocols.
• Hands-on experience with deviation management and CAPA processes.
• Proficient in document creation, report generation, and statistical analysis using PC-based tools.
• Comprehensive understanding of design control regulations throughout the product lifecycle.
• Solid knowledge of risk management regulations and processes, ensuring compliance and product safety.

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