Requirements Analysis Analyst 1

 
Work days/hours: M - F 8: 45am - 5: 45pm

DT required

This position is responsible for working in the Complaint Laboratory to perform product testing as well as planning, organizing, investgation write ups and tracking work activities. Quality results are expected to ensure the integrity of complaint investigations. Quality results are expected to ensure the integrity of Client UCC complaint investigations. 
   
Note: This is an In-Office position. 
 
Represents the Corporation, Division and Quality Department in a professional manner. 
   
•Provides support to Project Teams and Quality Department. 
   
•Responsible for all product testing in the Complaint Laboratory. 
   
•Provides Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review and investigation. 
   
•Performs complaint investigations for all UCC products and as applicable, for OEM manufactured products. 
   
•Creates investigation files in the complaint system (Trackwise). 
   
•Coordinates assigned complaint investigation files and works with the manufacturing site to complete the investigation timely. 
   
•Sets up, safely operates, and maintains laboratory equipment and testing instruments. 
   
•Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). 
   
•Develops and maintains a working knowledge of UCC policies and procedures and ISO and FDA requirements. 
   
• Maintains accurate data, analyzes and assists in drawing conclusions. 
   
•Performs tasks accurately and with great attention to detail. 
   
•Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by policies. 
   
•Ensures compliance to Department and Division procedures. 
   
•Interfaces with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups. 
   
•May present data findings to peers, engineering and management staff. 
   
•Technical competence in testing and writing and responsible for timely notifications based  on new information received to FA specialists to meet FDA reporting requirements. 
     
 
   
QUALIFICATIONS  
   
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements included in this job description are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
   
 
   
•Basic knowledge of medical device regulation, industry or international standard. 
   
•Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment. 
   
•Understanding of laboratory instrumentation. 
   
•Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory. 
   
•Broad knowledge of manufacturing processes. 
   
•Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. 
   
•Understands Fundamentals of Engineering Principles. 
   
•Ability to effectively manage time and manage priorities to meet deadlines. 
   
•Ability to handle multiple task assignments. 
   
•Ability to interpret Corporate, Division and Department Procedures. 
   
•Ability to work with minimal supervision. 
     
• Associate degree in a science field 
   
•Prior laboratory experience desirable 
   
•American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) is a plus 
   
• Proficiency with using MS Excel (pivot tables, v-lookup, etc.) 
   
• Minimum 2 to 3 years of experience with regulated industry, including co-op/internship experience 
 
   
LANGUAGE SKILLS 
   
Ability to read, analyze, and interpret general technical procedures or government regulations.  Ability to write simple reports and business correspondence.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 
 
REASONING ABILITY:
   
 This position requires good judgment.  All product and process development are to be carried out according to the applicable laws and regulations.  When in doubt, the incumbent should source out the appropriate information via internal and external resources. 
   
•Highly variable operations performed daily from complex regulatory and engineering decisions to routine administrative functions.  Interpretation of regulations (GMP, ISO 13485, EN46001) into standards and procedures as required.  The ability to explain these interpretations to Plant, Division, Corporate and representatives of Regulatory bodies is necessary. 
   
•A great deal of work must be initiated through a detailed knowledge and understanding of the job function, the establishment of plans to attain the end goal.   
   
•Decisions made by this person could have significant regulatory and financial implications.  Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients. 
 
PHYSICAL DEMANDS:
While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear.  The employee will sometimes be required to move around in lab environment.  Specific vision abilities required by this job include close vision and color vision.  May occasionally lift objects up to 25 lbs.