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BD (Becton, Dickinson and Company) Quality Assurance Operations Manager in Covington, Georgia

Job Description Summary

Job Description

The Quality Assurance Operations Manager has the responsibility of managing the Covington Operations (Cov Ops) QA/QC functions for IQC, Kitting, Production, Rework and maintaining the quality system structure and registrations for Bld. A and at GDC kitting location. This includes the responsibility to maintain a department of well educated, trained, and motivated staff. This includes providing them with the tools and guidance to be successful in performing their work, as well as providing them with a work environment conducive to personal and professional development for success.

The primary functions are associated with Incoming Quality Control (e.g., Inspection Protocol, Re-inspections and Ship to Stock), Manufacturing (e.g., production, kitting, testing, rework), Materials Management, Labeling, and Hold, Release, Reject, Return to Vendor, Scrap, and Not for Human Use product disposition management along with maintenance of the quality system for Covington UCC Kitting & IQC.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Represents the Corporation, Division, Facility and Quality Department in a professional manner

• Creates and maintains the quality system structure and registrations for Covington Bld. A.

• Manages QC functions associated with Covington Operations activities (e.g., inspection, testing, production, kitting, rework, product release) and optimizes the product flow of products from manufacturing plants through Bld. A to distribution.

• Identifies and drives process improvements (IQC, Production, Kitting).

• Member of CAPA Review Board for Cov Ops, providing oversight for CAPA execution related to Cov Ops teams.

• Manages non-conformance trends for the Cov Ops and provide oversight for corrections, trending, tracking, external communications, closure and reporting.

• Prepares and maintains department budgets.

• Interfaces effectively with senior leadership regarding Cov Ops.

• Supports internal and external audits/inspections of the Cov Ops activities and documentation.

• Hires, trains, develops, reviews and manages exempt and non-exempt employees (to include PMCP adherence and employee development deployment).

• Provides management support in resolution of non-conformances.

• Prepares and implements facility policies and procedures relating to quality.

• Creates, reviews and approves Quality System documents (e.g., EI/PS, IPs, quarantine, waivers, rework, validation).

• Creates, reviews and approves protocols and summary reports.

• Builds relationships with and supports other business units and corporate initiatives related to IQC and Kitting.

• Analyzes process and product non-conformances and implements/manages comprehensive corrective and preventive action plans.

• Performs Internal Quality System and Supplier audits, as assigned.

QUALIFICATIONS

To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Verbal communication skills and presentation skills: Ability to create and understands how to present information dependent upon the level of the audience.

• Technical writing skills: Ability to create reports, presentations, rework protocols, validation protocols, metrics, procedures, forms, flowcharts, quality plans, quality agreements, etc., and review and approve technical documentation, as required.

• Management skills: Ability to prioritize resources based on changing business needs.

• Budgeting skills: Ability to control costs while providing appropriate resources in order to maintain compliance posture while meeting business needs.

• Computer skills: Ability to create and manage technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems.

• Knowledge of medical device regulation, industry or international standards. Ability to understand Organization, Corporate, Business Unit, and other Facilities Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.

• Knowledge and demonstrated use of Document Control, Training, Time Management, and Investigation Techniques (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys) practices.

• Ability to interpret Regulations, Organization, Corporate, Business Unit, Facility and Department Procedures.

• Comprehensive knowledge of quality systems and relationship to business.

• Broad understanding of auditing principles and ability to become qualified as a lead auditor.

• Comprehensive knowledge of inspection, testing, product release, manufacturing processes and associated systems.

• Fundamental knowledge of validation principles.

• Understands basic applied statistics, statistical sampling plans, and statistical process control.

• Ability to serve in leadership roles on projects or assignments.

• Ability to identify opportunities for quality and cost improvements.

• Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understand team functions, leadership techniques and project management methodologies.

• Ability to effectively manage time.

• Ability to handle multiple task assignments.

• Ability to translate quality requirements into product specifications.

• Ensures synergy and compliance to Corporate, Segment, Business Unit, and Department procedures.

• Develops, tracks, trends, reports and maintains Quality Indicators to enhance quality of products and business performance.

• Participates in the implementation of Lean Manufacturing/Inspection Methodologies and 6-S Program activities

• Manages QA/QC resources with respect to meeting Corporate-wide priorities to assure business continuity.

EDUCATION and/or EXPERIENCE

• Four (4) year Science, Engineering, Technology or Business Degree.

• Eight (8) years’ experience in a decision-making quality position with at least four (4) years in FDA/ISO/OSHA/etc. regulated industry (pharmaceutical / medical device).

• Three (3) plus years' management experience in a quality management role.

• Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing.

• Additional preferable skills include use of basic applied statistics, ability to determine statistical sampling plans, implementation of statistical process control, DOE and Taguchi Methodology.

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.

#LI-PRO

Primary Work LocationUSA GA - Covington BMD

Additional LocationsUSA GA - Covington Global Dist Center

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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