Continuous Improvement Quality Engineer (CIQE)

Job description

Primary Function of the Position Ensure that quality systems, products, and manufacturing processes comply with quality standards by supporting and driving improvements in the organization and in accordance with international industry practices and regulations (e.g., ISO 13485, 21CFR820). Meet objectives, provide support and expertise in NC & corrective and preventive action (CAPA) process and system and implementing actions to drive the improvement.

S/he will partner with subject matter experts on various NC/CAPA activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation, identification, and robust investigation of product quality and compliance issues within a closed-loop quality management system.

Essential Job Duties

Support and comply with Company and Site’s Health, Safety, and Environmental programs and requirements, including: Use of personal protective equipment (PPE) as applicable. Use devices, accessories, tools, and equipment according to the process, verifying that they are in good condition for use and reporting those that are in poor condition for repair. Communicates unsafe acts or conditions to their superiors. Participates in the Health, Safety, and Environment courses established.

Maintains order and cleanliness in the workstation (5S) under responsibility. Complies with health regulatory and International Standard (ISO13485) requirements, Company and site policies, operating procedures, processes, and task assignments. Participate in or lead completion of NC & CAPA projects, assuring compliance, quality, and timeliness of records. Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.

Lead and collaborate with cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving skills). Independently investigate, gather data, trends, and perform preliminary analysis. Process requests, ensuring subject matter experts and action item owners are assigned and provide timely responses in alignment with quality goals. Leads meetings and communications for NC/CAPA updates, information, and concerns.

Responsible for assisting with metrics and reporting in accordance with established procedures. Support the team in delivering and overseeing the NC & CAPA training program. Assist in initiating, processing, and completing NC & CAPA records in the electronic system. Execute and provide on-time completion of Quality Engineering deliverables. Provide support and NC’s or CAPA’s process/system subject matter expertise during audits and inspections.

Support the review and approval of any documentation required by NC/CAPA deliverables. Mentor CAPA teams and colleagues who are beginner-level in NC/CAPA processes and systems.

Qualifications

Required Skills and Experience

Quality Engineer: Systems, Assurance, or Quality Control

• Minimum 4 Years experience Have worked in a regulated manufacturing industry: Medical devices, Pharmaceuticals, Aerospace, Automobile, Food, etc.
• Minimum 4 Years Previous NC & CAPA and/or engineering experience and demonstrated use of quality tools/methodologies.
• Minimum 4 Years of work experience Detailed knowledge of Quality System Regulations (21CFR820) and ISO 13485.
• Minimum 3 Years Ability to work in a highly matrixed and geographically diverse business environment Quality/Compliance focus and attention to detail Critical thinking skills for analyzing risk, use of root cause analysis tools, and technical aptitude to collect and analyze data for determining an improvement strategy Expertise in cGMP and NC/CAPA documentation Computer skills (advanced Microsoft Office Package and statistical/data analysis and report writing skills) Demonstrated impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Ability to work within a team and as an individual contributor in a fast-paced, changing environment Ability to leverage and/or engage others to accomplish projects Strong verbal/written communication skills with ability to communicate effectively at multiple organizational levels Multi-tasks, prioritizes. and meets deadlines in a timely manner Strong interpersonal, organizational, and follow-up skills Passionate about making products and processes better Required Education and Training Engineering Bachelor’s degree
• Preferably in science or healthcare fields. Working Conditions Desk and meeting rooms

Preferred Skills and Experience

ASQ certification : CQE, CQA, Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus NC or CAPA Review and Approval Project Management experience Experience working in a broader enterprise/cross-division business unit model