Analyst , Analysis

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…