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.

Required Experience 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

Required Experience Sr QE
5 years’ experience within the quality function or Master’s Degree with minimum of 3 years' experience in quality.

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. 

Summary:
The QE II / Sr. QE will be responsible for developing quality assurance plans and procedures to ensure that all products produced at the site meet all applicable requirements of domestic and international regulations, GMPs and BD quality standards.   The role will support the site in ensuring compliance with these regulations through auditing, inspection and testing of processes, equipment and documentation. The position will also play a key role in driving continuous improvement initiatives by identifying non-conformances and providing solutions to prevent their recurrence.   In addition, this individual will provide training to associates as needed.

Responsibilities:

• Developing quality assurance plans and procedures to ensure all products produced at the site meet all applicable regulatory requirements, GMPs and BD quality standards.

• Perform internal audits to identify non-conformance issues and potential risks to product quality.   Provide feedback to management on identified issues and recommend appropriate corrective action.

• Support the development and implementation of effective corrective actions to address identified issues.

• Manage relations with external customers/agencies regarding quality issues.

• Collaborating with manufacturing operations to implement robust quality systems and procedures.

• Coordinating URS, IRA and PPAP reviews for suppliers.

• Participating in cross functional teams focused on process improvements and new product introductions.

• Reviewing and approving validation protocols and reports.

• Approving changes to master production schedules and batch records.

• Training associates as needed.

Qualifications:

• Bachelor’s degree in Engineering or related discipline preferred.

• Minimum of 2 years relevant experience required.

• Strong computer skills including Microsoft Office Suite.

• Ability to work independently and as part of a team.

• Excellent communication skills.

• Knowledge of FDA cGMPs and ISO 13485.

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/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. 

Required Skills

Optional Skills

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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

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