Quality Engineer II / Sr Quality Engineer at BD Canada

, , United States -

Full Time

Start Date

Immediate

Expiry Date

25 Jan, 26

Salary

121000.0

Posted On

27 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Quality Assurance, Quality Control, Statistical Analysis, Continuous Improvement, CAPA, FMEA, Risk Analysis, Project Management, ISO 13485, FDA Regulations, Change Control, Supplier Quality, Training, Documentation, Auditing

Industry

Medical Equipment Manufacturing

Description

Job Description Summary The Quality Engineer II/Sr title will be determined based on prior experience. The general requirements will be the same. The degree of independence and oversight will vary based on the associate being determined to be a QEII or Sr QE. This position is responsible for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant. 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 continuous improvement (internal/external). Responsibility for process validation across all media plants. 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. Will support both internal and external audits. Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/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. Responsibility for CAPAs and may lead the investigation/corrective action process. Responsible for day to day QM Engineering responsibilities for product and related operational areas. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives. Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Responsibilities: Required experience in independently writing and executing process validation protocols. Experience in a medical device or pharmaceutical manufacturing facility. Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485 Clinical Diagnostic experience a plus Ability and skill to effectively manage multiple tasks and drive execution of change management plans Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC Provide on site validations of equipment, software and materials, for the Baltimore/Sparks reagent plants. Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies. Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments. Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, trending and design control. Initiates and/or supports CAPAs and may lead the investigation/corrective action process Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products. Responsible for initiating and coordinating SAP master data and documentation for product changes and new products. Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes. Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures to support operations day to day. Supports internal and external audits and assists in administering the audit program. 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. Facilitates investigation of customer complaints. Implement revision to TI's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints. Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met To be considered for a Sr QE Bachelor's degree and 5 Years’ experience within the quality function or Master’s Degree with minimum of 3 years' experience in quality. To be considered for a QEII Bachelor's degree. Typical degree in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role. Advanced degree can make up for experience requirement 2+ years experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics. Required Skills Optional Skills . Primary Work Location USA MD - Hunt Valley Additional Locations Work Shift NA (United States of America) At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $73,300.00 - $121,000.00 USD Annual We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Responsibilities

The Quality Engineer II/Sr is responsible for applying and interpreting Quality Systems, developing and implementing Standard Operating Procedures, and ensuring compliance with documentation processes. This role also involves monitoring quality indicators, supporting audits, and leading investigations and corrective actions.