Quality Engineer I

Job Description SummaryQuality Engineer I supporting Liberator Medical Supply (LMS)Job DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.SUMMARYThe Quality Engineer is primarily responsible for reviewing and assessing Quality Notifications/Nonconformities, Deviations/Waivers, and other cGMP activities for the assigned product lines shipped to Liberator Medical Supply (LMS) customers. This position oversees Quality Control operations within LMS and assuring documentation and procedures are followed, updated, and maintained as required by internal Quality Policies and related FDA/GMP guidelines. The Quality Engineer conducts investigations assists in the investigation of issues and provides data and input on technical issues and projects.ESSENTIAL DUTIES AND RESPONSIBILITIESRepresents the Corporation, Division and Quality Department in a professional manner.

Provides support to Project Teams and Quality Department.

Performs investigations for all LMS products, as needed.

Manages completion of assigned investigation files and works with the manufacturing/Business unit site, where necessary, to complete the investigation within a timely fashion.

Creates, reviews and approves Quality System Documents (CAPA, Audits, supplier QA).

Creates, reviews and approves SOP Documents.

Develops and maintains a working knowledge of LMS and BD UCC policies and procedures and ISO and FDA requirements.

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

Performs tasks accurately and with great attention to detail.

Ensures compliance to Department and Division procedures.

Interfaces with manufacturing facilities, suppliers, and PLM groups, as applicable.

May present data findings to peers, engineering and management staff.

Technical competence in testing and writing.

QUALIFICATIONSTo 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 understanding of OSHA requirements, Quality Systems Regulations (QSR), 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 EXPERIENCEB.S. in Engineering, Engineering Technology, Science or related field 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)

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 ABILITYThis position requires good judgment. All 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 DEMANDSWhile 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.WORK ENVIRONMENTMinimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings. This position works in a normal lab/office environment. The noise level in the work environment is quiet to moderate.For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.To learn more about BD visit https://jobs.bd.com/Becton, 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.PDNPrimary Work LocationUSA FL - Stuart Airport RoadAdditional LocationsUSA GA - Covington BMDWork 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.