Quality Engineer II

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Location :
Sparks, Maryland

Expiry Date :
Mon, 08 Mar 2021 23:59:59 GMT

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Job Description Summary Job Description Be 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. BD is hiring a Senior Quality Engineer Design based out of Sparks, MD! This position has responsibility for interpreting the Quality Systems. Developing and implementing Standard Operating Procedures and policies for various groups such as quality control or manufacturing. Maintain schedules and timelines. Ensures the documentation process remains in line with BD standards. The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Supervising and trending quality indicators for purchased materials as well as manufactured and distributed products. Assesses Critical-to-Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may own the investigation and corrective action process. Responsible for aspects of Media QM Engineering as well as the day to day QM Engineering responsibilities for assigned product and related operational areas. Directly responsible to the Plant Quality Manager for the continued consistent implementation/application of Quality Systems as it relates to new and current product lines and Enterprise business systems. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting internal and external audits, participation on teams, assigned project support, product launches and process improvements, and coordination and resolution of CAPAs, product quality notifications, change notifications and customer complaints. This includes using Enterprise tools to ensure compliance and streamlining the processes. In this role you will be responsible for: Responsibilities – Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies. – Provides advice, updates, and solving quality product and processes using technical and enterprise knowledge independently and in team collaboration. Consults more Senior Quality personnel for sophisticated issues. – Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans and design control. – Supports implementation of corrective actions and improvements by systemizing SAP data/documentation for specific Quality Notifications. – Responsible for initiating and coordinating SAP master data and documentation for product changes and new products. – Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures. – Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals, and provides plant quality metrics as required to generate quality system improvements. – Implement revision to documents based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints. – Define Change Control requirements for the plant related to manufacturing, facility and material changes. To be successful in this role, you should be able to demonstrate: Requirements – Bachelor’s degree. Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs or other related field. – 2+ years experience in Quality, Quality Control, or Quality related complaint handling. Preferred and additional skills and qualifications – 3 to 8 years of experience in a manufacturing, supply chain,or manufacturing support role with exposure to high volume and or high quality medical device manufacturing – Optimally lead numerous projects/tasks and drive execution of organizational change plans – Lead or innovate process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC – Ability to successfully write communications that ensures visibility, accuracy and consideration of the audience – Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations – Listen to others; including associates, managers, peers and customers when making decisions and solving problems – Strong statistical analysis skills with the ability to apply sophisticated mathematical concepts such tasks as frequency distributions, reliability testing, analysis of variance, correlation studies and sampling theory. – Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820, ISO 13485:2016, EU IVDR Requirements We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #LI-ISC #LI-PRO Why join us? A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your lifes purpose through the work that you 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 learn more about BD visit Primary Work LocationUSA MD – Sparks – 7 Loveton Circle Additional Locations Work Shift