Analyst 1, Requirements Analysis

This role is responsible for conducting and documenting comprehensive complaint investigations, including product testing, and effectively planning, organizing, and tracking all activities associated with complaint records. The position requires a strong commitment to quality and accuracy to ensure the integrity, completeness, and regulatory compliance of Client UCC complaint investigations. Success in this role is driven by active in-office collaboration, enabling real-time engagement with experienced investigators, cross-functional partners, and laboratory teams to accelerate learning, enhance problem-solving, and ensure timely resolution of issues. This onsite presence also supports knowledge sharing, team alignment, and the ability to contribute to both individual and departmental priorities.

Conducts comprehensive complaint investigations for all UCC products, including OEM-manufactured products.

• Executes laboratory testing and experiments in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

• Accurately documents data, performs detailed analysis, and supports the development of evidence-based conclusions.

• Works safely within a biohazard environment, strictly adhering to all safety policies and procedures.

• Provides Quality Engineering technical support to address and resolve product quality issues, including complaint review and investigation.

• Manages assigned complaint investigation records and collaborates with manufacturing sites to ensure timely and thorough resolution.

• Prepares, operates, and maintains laboratory equipment and testing instruments in a safe and compliant manner.

• Develops and maintains a strong working knowledge of UCC policies, procedures, and regulatory requirements (ISO, FDA).

• Demonstrates a high level of accuracy and attention to detail in all aspects of work.

• Collaborates with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) teams, and Quality Engineers to support investigation activities.

• Communicates findings effectively and may present investigation results to peers, engineering teams, and management.

• Applies technical expertise in sample testing and investigation documentation, ensuring timely escalation of newly identified complaints and reporting in accordance with FDA requirements.

• This role requires in-office presence to accelerate onboarding and skill development through hands-on learning, peer coaching, and real-time collaboration with experienced investigators.

• In-person collaboration is essential to facilitate timely issue resolution, effective cross-functional communication, and alignment with internal and external stakeholders.

• Onsite availability enables proactive support of team priorities, allowing the investigator to assist colleagues with complex cases, contribute to improvement projects, and strengthen overall department performance.
  

  Knowledge and Skills:

  QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty effectively. The requirements below represent the knowledge, skills, and abilities needed for success. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Working knowledge of medical device regulations and standards, including FDA, ISO, QSR, GLP, and applicable industry guidelines (e.g., AAMI). Strong laboratory skills, including hands-on experience with bench testing methods, instrumentation, and troubleshooting of equipment. Understanding of manufacturing processes and their impact on product quality and complaint investigation outcomes. Effective communication skills (verbal and written), with the ability to tailor messaging and present technical findings clearly to diverse audiences. Solid understanding of fundamental engineering and scientific principles applied to product evaluation and root cause analysis. Strong organizational and time management skills, with the ability to prioritize multiple tasks, meet deadlines, and manage shifting priorities. Ability to interpret and apply corporate, division, and departmental procedures within a regulated environment. Self-motivated with the ability to work independently while also collaborating effectively in a team-based, in-office environment. LANGUAGE SKILLS Ability to read, analyze, and interpret technical procedures, scientific data, and government regulations applicable to a regulated industry. Ability to prepare clear, concise, and well-structured investigation reports, technical documentation, and business correspondence. Effective verbal and written communication skills, with the ability to present technical information and respond to questions from cross-functional teams, management, customers, and external stakeholders. REASONING ABILITY Applies sound judgment in evaluating product complaints and investigation results, ensuring all activities are conducted in compliance with applicable regulatory requirements, standards, and internal procedures; proactively seeks guidance and leverages internal/external resources when needed. Navigates a dynamic work environment involving a range of activities—from complex regulatory and technical decision-making to routine administrative tasks—while accurately interpreting and applying regulations (e.g., GMP, ISO 13485) into practical standards and procedures. Demonstrates the ability to develop structured approaches to investigations, including defining problems, analyzing data, and formulating evidence-based conclusions to achieve desired outcomes. Effectively communicates regulatory and technical interpretations to cross-functional stakeholders, including plant, division, corporate teams, and regulatory representatives. Recognizes the significant regulatory, financial, and patient safety impact of decisions, exercising a high level of accountability, critical thinking, and attention to detail in all investigative activities.

  Physical Demands: (if applicable)

  While performing the duties of this position, the employee is regularly required to sit, stand, walk, and communicate effectively, including talking and listening. The role involves periodic movement within a laboratory or production environment to support testing, investigations, and collaboration activities. Specific vision abilities required include close vision, color vision, and the ability to focus on detailed work such as sample evaluation and data analysis. The employee may occasionally be required to lift and/or move items weighing up to 25 pounds. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the role.

  Work Environment: (if applicable)

  The work environment for this position is primarily office and laboratory setting with generally quiet to moderate noise levels. The role involves minimal exposure to manufacturing environments, which may include occasional noise, slight temperature variations, and limited exposure to chemical fumes under controlled conditions. The position requires the safe operation, handling, and maintenance of laboratory testing equipment and measurement instruments, in accordance with established safety and regulatory standards.