Job Description Summary

Job Description

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.

ESSENTIAL FUNCTIONS
1. 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.
2. Analyzes complaint data and reports trends and triggers for significant complaint issues. Trends complaint data to identify significant changes and identifies chronic complaint categories.
3. Documents all activities regarding complaint analysis, failure investigation, corrective action, preventive action, and efficiency. Maintains customer complaint related files per policy/procedures.
4. Handles returned samples in a safe manner, taking all vital precautions related to contaminated and ‘sharp’ products.
5. Audits corrective actions implemented to remedy complaints for efficiency.
6. May participate in the site’s internal / external auditing function, developing audit reports and communicate them to auditees and the quality group.
7. Conducts quality training as the need arises to ensure compliance with Federal Regulations and International Standards where appropriate.
8. Manages corrective/preventive action system 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.
9. Manages the plant internal audit program as assigned to ensure compliance as the need arises.
10. 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 vital.
11. Conducts supplier audits with QSR/ISO as advised by material requirements and company guidelines.

ADDITIONAL RESPONSIBILITIES
1. Performs dimensional inspections for all departments as needed.
2. Performs miscellaneous duties as the need arises.

Education

BA/BS Degree (Engineering or related science) with minimum of an internship (Required)

BA/BS Degree (Engineering or Biological science) with minimum of two years of experience in complaint handling, problem solving or quality system in a related field (Preferred)

Masters Degree (Engineering or Biological science) with minimum of an internship (Preferred).

Experience and Knowledge

• Solid understanding and/or experience in a regulated industry. FDA and medical device experience (Preferred).
• Familiar with the basic concepts, principles, and techniques for auditing (Preferred)
• Requires a command of interpersonal relations and communication, investigate skills, and analytical techniques in order to assess evidence, make decisions, and report findings (Required).

About Becton Dickinson (BD):
At BD Becton, Dickinson & Co., you are one person making one big difference. You are a key member of a team that is a meaningful part of a leading, purposeful company committed to advancing the world of health. No matter what role you play, you can be confident that you are improving lives, all over the world. And as you progress with us, your impact will only grow.

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.

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Additional Locations

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