Quality Engineer I

Quality Engineer

I 3.0 3.0

out of 5 stars 8000 Castleway Drive, Indianapolis, IN 46250 Cork Medical 29 reviews ob

Summary:

The Quality Engineer is responsible for ensuring compliance with regulatory requirements and maintaining the effectiveness of the Quality Management System (QMS). This role oversees quality metrics, CAPA programs, supplier management, and training initiatives. The position requires strong analytical skills, attention to detail, and the ability to collaborate across departments to drive continuous improvement and maintain audit readiness.

Duties/Responsibilities:

Quality Metrics Processes for Products and QMS Performance - Responsibilities Lead and facilitate monthly quality review meetings to evaluate product performance and overall QMS effectiveness. Integrate key quality and performance metrics into the Quarterly Management Review to support data-driven decision-making. Monitor performance trends and initiate nonconformances (NCs) when metrics fall below defined targets or expectations. Oversee the management and resolution of NCs generated from quality metrics, ensuring timely corrective actions and continuous improvement. CAPA Program Management - Responsibilities Provide training to associates on the Corrective and Preventive Action (CAPA) process, including the use of root cause analysis tools. Assess quality issues to determine when a CAPA should be initiated, and support associates in developing effective correction, corrective, and preventive action plans. Monitor the progress of CAPAs to ensure timely investigation, implementation, and closure. Evaluate the effectiveness of all CAPAs to confirm that the root cause has been addressed and recurrence is prevented. QMS Training Awareness Program- Responsibilities Deliver new hire onboarding focused on expectations within a regulated environment, including an overview of quality system requirements. Develop and implement training programs on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) for both operations and office personnel. Continue the MDSAP Chapter Training Program in collaboration with applicable Subject Matter Experts (SMEs) to ensure ongoing regulatory compliance and awareness. Supplier Management Process - Responsibilities Provide oversight of the supplier's qualifications and selection process, ensuring suppliers are capable of consistently meeting specified requirements. Conduct comprehensive supplier assessments to qualify vendors based on their ability to deliver conforming products or services. Maintain and regularly update the Approved Supplier List (ASL) to reflect current qualified suppliers. Implement and enforce procedures to ensure that only approved suppliers are used for the procurement of materials and services. Oversee ongoing supplier monitoring and auditing activities to evaluate performance and compliance. Establish and maintain quality agreements with suppliers that clearly define quality expectations, roles, and responsibilities. Include provisions in agreements for managing nonconforming products and implementing corrective actions when necessary. Conduct risk assessments related to suppliers and the products or services they provide and manage those risks accordingly. Maintain complete and accurate records of supplier evaluations, qualifications, audits, and performance reviews. Ensure all supplier-related documentation is readily accessible for regulatory audits and inspections.

Required Skills/Abilities:

Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Extensive knowledge of or the ability to quickly learn the organization's production processes. Excellent interpersonal skills with ability to serve as a liaison with developers, project managers, and customer support. Strong analytical and problem-solving skills. Proficient with Microsoft Office Suite or related software.

Education and Experience:

Bachelor's degree in engineering or a related field is preferred. Proven experience in quality engineering or a similar role within a manufacturing or healthcare environment. Familiarity with quality audits, ISO 13485, ISO 9001, FDA regulations, and CGMP practices is essential. Strong analytical skills with the ability to interpret complex data sets effectively. Excellent communication skills, both verbal and written, with the ability to work collaboratively in a team environment. Knowledge of QA/QC methodologies and tools is highly desirable.

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer. Must be able to lift to 15 pounds at times.