Quality System Specialist II
BD
Sumter, South Carolina
Full-Time
Competitive
OfficeSenior
We are the people who give possibilities purpose
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.
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
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://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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