Quality System Specialist II

Becton Dickinson Medical Devices•Sumter, SC

2d•Onsite

About The Position

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. 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.

Requirements

BA/BS Degree required, (Engineering or related Science 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.
Working knowledge and/or experience in a regulated industry.
FDA and medical device experience - preferred
Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.

Nice To Haves

Master Degree (Engineering or Biological Sciences) - preferred.
Auditing certification (ex: ASQ CQA, Exemplar global, BSI) -preferred

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’s corrective/preventive action 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.