BD (Becton, Dickinson and Company) Quality System Specialist - Compliance in Broken Bow, Nebraska
Job Description Summary
Responsible to the Associate Manager Quality – Compliance for management of the plant’s corrective/preventive actions, internal audits system, and other activities related to FDA and ISO compliance. 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.
The essential functions of this position include but are not limited to:
Develops, administers and maintains the Quality System for conformance to Federal Regulations, International Standards and Corporate Policies/Procedures. Be familiar with products manufactured as well as the manufacturing process to assure compliance to Federal Regulations and International Standards as required.
Manages the plant’s corrective/preventive action system to assure consistency and accuracy of specifications and procedures necessary to manufacture products of the highest quality.
Actively participates in monthly Quality Data Analysis (QDA) meetings and provide feedback as pertaining to Continuous Improvements.
Owns the plant internal audit program to ensure compliance to Federal Regulations and International Standards as required.
Plans and performs intensive audits of the plant systems and procedures. Coordinates plant audit teams to include training, scheduling, performing and reporting of audit.
Conducts supplier audits to ensure compliance with QSR/ISO as directed by material requirements and company guidelines.
Assists Quality Assurance personnel in addressing quality issues, as appropriate.
Conducts quality training as required to ensure compliance with Federal Regulations and International Standards where appropriate. Responsible for Quality Awareness and Good Manufacturing Practices training at all employee levels.
Works with other departments to maintain the highest quality standards.
SAFETY AND ENVIRONMENTAL PERFORMANCE STANDARDS
Other responsibilities of this position include but are not limited to:
Complies with, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures.
Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual - BD Broken Bow.
Performs other job related duties as assigned.
Observes all safety, environmental and quality system standards.
All requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their facilitator. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently. This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.
EDUCATION, EXPERIENCE AND SKILLS REQUIRED
- B.S. or B.A. Degree required. Degrees in a Science or Engineering field with strong emphasis or experience in Quality Assurance and/or Mathematics/Statistics are preferred.
Must possess a broad knowledge of products and manufacturing processes.
Prefer a working knowledge of inspection techniques, auditing, process capability studies, GMP and quality theories.
To learn more about BD visit https://jobs.bd.com/
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, or any other protected status
Level 1 - Sedentary Work: Exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently. Involves sitting most of the time, but may involve walking or standing.
Strong verbal, written, analytical, persuasion and interpersonal skills.
Ability to manually operate a computer with a standard keyboard.
The position is subject to inside environmental conditions typically associated with an office environment. The amount of travel associated with this position may be considerable.
This position reports directly to the Associate Manager Quality - Compliance
Primary Work Location
USA NE - Broken Bow
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, or any other protected status.