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This position is responsible for working in the Bard Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. Quality results are expected to ensure the integrity of Bard complaint investigations. Additionally, the Quality Engineer functions as a subject-matter resource for Engineering, Operations, Sterilization and outside suppliers.
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
Creates investigation files in the BARD Global complaint system (Trackwise).
Performs complaint investigations for all BMD and OEM manufactured products.
Manages completion of assigned complaint investigation files and works with the manufacturing site or suppliers where necessary, to complete the investigation within a timely fashion.
Provides support to Project Teams and Quality Department.
Creates, reviews and approves Quality System Documents (SOP, CAPA, Audits, SPAs and R002s)
Sets up, safely operates, and maintains laboratory equipment and testing instruments.
Responsible for all products testing in the Complaint Laboratory in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Develops and maintains a working knowledge of BMD policies and procedures and ISO and FDA requirements and ensures compliance to Department and Division procedures.
Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis . May present data findings to peers, engineering and management staff.
Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Bard policies
Performs tasks accurately and with great attention to detail.
Technical competence in testing and writing and responsible for timely notifications based on new information received to FA specialists to meet FDA reporting requirements.
Represents the Corporation, Division and Quality Department in a professional manner.
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.
Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.
Basic knowledge of medical device regulation, industry or international standard.
Broad knowledge of Medical Device complaint reporting requirements.
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.
Ability to work in a team.
EDUCATION And/or EXPERIENCE
Prior laboratory experience desirable
B.S. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
Experience with Access Databases, Excel (PIVOT Tables and Charts) and complaint handling software (Trackwise or Pilgram)
Quality Engineer I
Minimum 1 to 3 years of experience with regulated industry, including co-op/internship experience
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Staffing and Recruiting
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