Quality System Specialist II
Onsite, Sumter, Carolina, do, Sul
Job Description Summary
The Quality System Specialist II is responsible for management of the plant’s corrective/preventive actions, internal audits system, customer complaints and other activities related to FDA and ISO compliance as assigned. Supports the plant in identification and resolution of quality assurance and regulatory issues related to product lines to assure compliance with FDA regulations, ISO standards, Corporate directives and company strategies. Reports directly to the Quality Manager, Quality Systems.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:
Evaluates customer complaints; including the coordination of documentation review, sample testing, and root cause analysis. Leads and/or facilitates the compliant investigation to reduce or eliminate causes of the complaints.
Analyzes complaint data and reports trends and triggers for significant complaint issues. Trends complaint data to identify significant changes and identifies chronic complaint categories.
Documents all activities related to complaint analysis, failure investigation, corrective action, preventive action, and efficiency. Maintains customer complaint related files per policy/procedures.
Handles returned samples in a safe manner, taking all vital precautions related to contaminated and ‘sharp’ products.
Audits corrective actions implemented to remedy complaints for efficiency.
Participate in the site’s internal / external auditing function, developing audit reports and communicate them to auditees and the quality group.
Ensures compliance with Federal Regulations and International Standards where appropriate.
Manages the plant’scorrective/preventiveaction system as assigned to assure consistency and accuracy of specifications and procedures vital to manufacture products of the highest quality and compliance to regulatory and company requirements. Performs the Site CAPA Leader responsibilities as defined in established procedures.
Plans and performs intensive audits of the plant systems and procedures in accordance with established procedures.
Coordinates plant audit teams to include training, scheduling, performing and reporting of audit as necessary.
May conducts supplier audits to ensure compliance with ISO as directed by material requirements and company guidelines.
Performs dimensional inspections for all departments as needed.
Provide Continues Improvement solutions to their process, department or the facility.
Performs miscellaneous duties as required.
Education, experience and knowledge:
BA/BS Degree required, (Engineering or related Science preferred)
Master Degree (Engineering or Biological Sciences) - preferred.
Familiar with the concepts, principles, and techniques for auditing -required.
Requires a command of interpersonal relations and communication, investigate skills, and analytical techniques in order to clarify audit objectives, plan appropriate audit approaches, assess evidence, make decisions, and report findings.
Auditing certification (ex: ASQ CQA, Exemplar global, BSI) -preferred
Working knowledge and/or experience in a regulated industry. FDA and medical device experience - preferred
Work Environment:
BD is a smoke-free campus. Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas. We appreciate your cooperation in adhering to this policy
False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals. Any associate wearing dermals will be required to cover them while working on the production floor.
Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.
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 SC - SumterAdditional Locations
Work Shift
US BD 1st Shift 8am-5pm (United States of America)As pessoas aqui são incríveis, e sua paixão pelo que fazem transparece em tudo o que fazem.
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About BD
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.
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ