This position will support daily Quality Assurance operations to assist with implementing and maintaining the effectiveness of the Quality System.
Summary of Position with General Responsibilities:
This position serves as principal Quality Assurance (QA) personnel to assist with implementing and maintaining the effectiveness of the Quality System. This position performs various quality-engineering functions and associated support tasks in driving business objectives, developing knowledge and experience in the areas of 21 CFR 820 and 803, ISO 9001-13485, and MDD. This includes working to support Design Control projects as well as other duties in support of the Quality System, Document Control, Manufacturing department, and Investigations (CAPA, Complaints, Nonconformance, and Unscheduled Maintenance).
Essential job Functions:
Provide leadership and support for quality objectives and process improvement efforts, serving as designee for the QA Manager, as necessary.
Oversees and is accountable for overall compliance administration activities relating to QSR, Design Controls, Validations/Qualifications, and CAPA.
Lead, own, and/or provide guidance/mentoring for investigations (investigations pertaining to CAPA, Audit response(s), DMAIC/Failure Investigations, etc.).
Identify, implement, and monitor procedures and systems to support 21CFR§820, ISO 13485, and the European Medical Device Directive.
Ensures compliance to Department and Division procedures.
Provides support for Project Teams or Quality Department as required.
Oversees the Environmental Monitoring Program.
Oversees the Calibration Program.
Creates and reviews Quality System Documents.
Reviews Product Documents.
Creates/reviews Protocols, Process and Product Validations, and Test Methods.
Supervision of QA personnel as assigned.
Creates and reviews documents required for Design History File.
Creates and reviews Risk Assessments such as FMEA and/or FTA.
Performs Internal or Supplier Quality System Audits.
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
Interfaces with other Division Facilities as needed.
Travels as required by the above duties and responsibilities.
Understand and follow the established corporate safety standard, local facility operating procedures and safety policies.
Maintain regular and predictable attendance
Other Duties may be assigned, including but not limited to:
General quality control / quality assurance
Product testing and release
Raw material testing and release
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below 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.
Proficiency in variety of MicroSoft applications including Word, Excel, Visio, Powerpoint, and Minitab or applicable software.
Experience working with regulatory and statutory agencies (FDA, Notified Bodies, etc.).
Experience working with Lean and Six Sigma methodologies.
Ability to participate on teams and maintain positive work environment with those teams.
Demonstrated time management skills.
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications.
Ability to interpret Regulations, Corporate, Division and Department Procedures.
Education and/or Experience:
BA/BS in a scientific discipline (Engineering, Engineering Technology, Chemical/Biological or equivalent).
2 years medical device / pharmaceutical experience.
2 years of medical device /pharmaceutical validation, CAPA, complaint investigation, or quality system auditing experience.
Demonstrated knowledge and experience in problem solving, validations, CAPA, and investigations (Failure, DMAIC, complaint, etc.).
Proficiency in Microsoft Word, Access and Excel
ASQ certification (CQE, CQA, etc…) preferred
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle of feel. The employee is occasionally required to stand and reach with hands and arms and lift or move up to 25 lbs. Vision requirements include the ability to see and interact with computer as well as close vision.
This work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position works in an office and manufacturing environment. The noise level in the work environment is quiet to moderate. May include manufacturing or lab environment and certain work areas contain radioactive or hazardous chemicals.
Internal Number: R-339368
About Becton Dickinson/ CR Bard
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.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.