Job Description SummaryThis 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).The position provides leadership and facilitation of Quality Management activities. This position is responsible for monitoring the quality of medical devices to ensure they are manufactured and tested according to established methods and quality plans. The position is responsible for direct supervision, leadership, training, measuring and monitoring of processes and personnel, scheduling of QA technicians, and conducting performance reviews and making staffing recommendations and selections. # Job Description ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. + Train, schedule, and direct the work of the QA Technicians assigned to the Carol Stream facility. + Evaluate the performance of each individual, make recommendations concerning personnel additions, reductions, and transfers. + Provide timely and effective feedback to personnel based on individual quality and productivity performance among other competencies + Perform employee training and monitor departmental compliance with all applicable procedures and regulations + Make continuous quality evaluations and decisions concerning product quality. + Assure that all QA functions, including raw material and finished goods testing and release, are performed effectively to meet production schedule requirements. + Conduct team meetings to effectively communicate goals and production performance + 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. + Provides support for Project Teams or Quality Department as required. + Creates and reviews Quality System Documents. + Maintains the Validation Master Plan. + Creates/reviews Protocols, Process and Product Validations, Test Methods. + Creates and reviews documents required for Design Master File. + Creates and reviews Risk Assessments such as FMEA or FTA. + Lead, own, and/or provide guidance/mentoring for investigations (investigations pertaining to CAPA, Audit response(s), DMAIC/Failure Investigations, etc.) + Performs Internal and/or Supplier Quality System Audits. + Ensures compliance to Department, Business Unit and Corporate level procedures. + 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 Business Unit and Corporate 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. QUALIFICATIONS 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 lead teams and maintain positive work environment with those teams. + Strong technical and communication skills (verbal, written, and presentation). + Proficiency in internal and external (supplier) quality system auditing. + 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). + 5 years medical device / pharmaceutical experience; + 5 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.). + Experience working with regulatory agencies (FDA, BSI, etc.) + Proficiency in Microsoft Word, Access and Excel + ASQ certification (CQE, CQA, etc…) preferred # # LANGUAGE SKILLS Strong oral and written communication skills in English are required. Ability to effectively present information in one-on-one and group situations to supervisor, management and other employees of the organization. Ability to represent Corporate, Division and affiliates in a professional manner. # MATHEMATICAL SKILLS + College level mathematical skills. + Basic applied statistics. + Advanced statistics and/or 6 Sigma green belt certification is desirable REASONING ABILITY Judgment must be made based on consideration for applicable regulatory and statutory requirements and risks as well as Bard QS requirements. Decisions must include consideration for patient safety and QS effectiveness. As Design Control/ECR work and/or other responsibilities increase, so do the level of complexity and the importance of decision-making. PHYSICAL DEMANDS They 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 or 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. WORK ENVIRONMENT 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. Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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. #LI-PRO # Primary Work LocationUSA IL - Carol Stream # Additional Locations # Work Shift 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.