Job Description Summary

The facility QA Manager has the responsibility of leading the Quality Assurance Department and ensuring compliance to regulations, national and international standards, specifications and Corporate, Segment, Business Unit and internal policies and procedures. This includes the responsibility to lead a department of trained quality employees and to provide them with the tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional development for success. The QA Manager will also support Divisional business activities including new product and business development 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. 

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Coordinate the efforts of the staff functions with those of other departments in Carol Stream​​

• Participate in Quality System and Safety audits as required. Lead efforts to implement corrective actions and recommendations. 

• Lead a quality staff to ensure proper implementation and maintenance of a quality system in compliance with the Quality System Regulation, ISO 13485, National and International Standards, product specifications and Corporate, Segment, Business Unit and Internal policies and procedures. 

• Lead FDA & ISO Audits of the Carol Stream Facility 

• Lead management reviews for facility and lead continuous improvements projects. 

• Establish tracking and trending of quality indicators. Develop quality indicators to enhance quality of products and business performance. 

• Act as facility regulatory representative as delegated. 

• Create, review, and approve quality system programs and documents (CAPA’s, NCMR’s, SA’s, Quality Plans, Risk Assessments, etc.)  

• Establish quality plans to ensure that products conform to specifications. 

• Provide technical support for complaint review and investigation. 

• Provide quality assurance resources for investigating, analyzing, and resolving quality issues. 

• Responsible for attainment of plant and departmental goals and budget in support of overall plant objectives. 

• Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing, and hiring decisions and disciplinary actions 

• Other duties as assigned

Required Qualifications:

• Strong interpersonal skills required in the areas of verbal and written communications, presentation skills, consensus building, customer focus, professionalism, coaching, influencing, and team building. 

• Managerial skills, including technical writing, budgeting, and office software. 

• Extensive knowledge of medical device regulation, industry, or international standards. Proven understanding and application of sound managerial practices that support BD’s values 

• Ability to understand Division and Facility quality and safety systems and be able to implement systemic changes to enhance product quality and improve associate safety and efficiency. 

• Ability to effectively manage time and handle multiple assignments simultaneously. 

• Ability to translate quality requirements into product specifications. 

• Proficiency in Supplier and Quality System auditing. 

• Knowledge of Risk Assessment and Statistical Tools 

• Understands basic applied statistics, statistical sampling plans, and statistical process controls and advanced statistical methodologies such as DOE. 

• Ability to travel occasionally for supplier audits, training seminars, or Divisional business evaluations (approximately 5-10 days per year). 

• Experience with terminal sterilization techniques. 

• Excellent oral and written communication skills in English are required. 

• Ability to work in areas that contain radioactive materials 

Preferred Qualifications:

• Proficiency in JDE or comparable ERP systems

• American Society of Quality (ASQ) Certified Quality Auditor, Certified Quality Engineer, Certified Six Sigma Black Belt or Certified Quality Manager

Education and/or Experience:

• Bachelor’s Degree in Engineering or Science 

• Eight (8) years’ experience in a decision-making quality management position or equivalent quality related experience in FDA Regulated Industry. 

• Experience working with regulatory agencies (FDA, ISO Registrars, etc.) 

• Working knowledge of 21CFR Part 820 Quality System Regulation, ISO 13485, EU MDR, GMP, GLP 

• Working knowledge of the requirements for FDA and Notified Body regulatory submissions 

• Proficiency in Microsoft Word, Access, PowerPoint and Excel 

Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates.

Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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

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Primary Work Location

USA IL - Carol Stream

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

$115,200.00 - $189,700.00 USD Annual