Quality Engineer I

Job Description SummaryJob DescriptionThis 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.

Represents the Corporation, Division and Quality Department in a professional manner.

Provides support to Project Teams and Quality Department.

Responsible for all products testing in the Complaint Laboratory.

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, where necessary, to complete the investigation within a timely fashion.

Creates, reviews and approves Quality System Documents (CAPA, Audits, SPAs and R002s)

Creates, reviews and approves SOP Documents.

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 BMD policies and procedures and ISO and FDA requirements.

Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis .

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 Bard policies

Ensures compliance to Department and Division procedures.

Interfaces with manufacturing facilities, suppliers, and 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.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.

LANGUAGE SKILLSAbility 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. There is a great deal of freedom of action, originality and imaginative drive and critical analysis since there is not strict day-to-day supervision. The success of implementation of quality plans is largely dependent upon the person’s ability to recognize the most efficient, cost-effective approach to attaining the desired goal. In many instances, the person will be required to use creativity and imagination in carrying out the job function. This person will be working in a fast-paced, technically challenging environment where drive is critical to success.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.