C. R. Bard, Inc.

Quality Assurance Manager - Sterility Assurance - Operations

Posted Date 3 weeks ago(1/29/2018 11:18 AM)
Industry / Category
Quality Assurance Manager/Quality
Job ID
2018-11092
Career Level
experienced
Division
Bard Medical Division
Relocation
Yes
Location
US-GA-Covington

Overview

The Quality Assurance Manager - Sterility Assurance - Operations is located at BD UCC Division in Covington, GA.

Summary of Position with General Responsibilities

The Shared Services Manager, Quality Assurance – Covington Operations has the responsibility of managing the Covington Operations (Cov Ops) QA/QC functions. 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.

 

Essential Job Functions

  • Represents the Corporation, Division, Facility and Quality Department in a professional manner
  • Manages QC functions associated with Covington Operations activities (e.g., inspection, testing, production, kitting, rework, product release)
  • Member of CAPA Review Board for Cov Ops, providing oversight for Event/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
  • 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., I/PS, IPs, quarantine, waivers, rework, validation)
  • Creates, reviews and approves protocols and summary reports
  • Analyzes process and product non-conformances and implements/manages comprehensive corrective and preventive action plans
  • Performs Internal Quality System and Supplier audits, as assigned
  • Ensures synergy and compliance to Corporate, Division, Facility 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

 

Basic Qualifications

  • 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, rework protocols, validation protocols, metrics, reports, 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, Division 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 (e.g., CAPA, non-conformance, thresholds, fishbone, 5-Whys) practices.
  • Ability to interpret Regulations, Organization, Corporate, Division, Facility and Department Procedures.
  • Comprehensive knowledge of quality systems and relationship to business.
  • Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
  • Broad 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.

 

 

Additional Desirable Qualifications Skills and Knowledge

LANGUAGE SKILLS  

 

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures/forms. Ability to effectively present information and respond to questions from groups of managers, peers and the general public.

 

MATHEMATICAL SKILLS

 

  • College level mathematical skills (e.g., addition, subtraction, multiply, divide, fractions, percent, deviation).
  • Versed in statistics, modeling, optimization, data presentation and analysis and application to business problems.
  • Basic Applied Statistics, Statistical Sampling Plans, Statistical process control, DOE and Taguchi Methodology.

 

REASONING ABILITY

 

  • This person will be working in a fast-paced, technically challenging environment where drive is critical to success.
  • Decisions made by this person could have significant regulatory and financial implications. Furthermore, this person’s decisions could have a significant impact on health care practitioners and the welfare of their patients.
  • Highly variable operations performed daily, from complex regulatory and engineering decisions to routine administrative functions. This position involves reviewing and making decisions involving Personnel, Statistics, Document Control, Policy, Procedure, Specifications, Quality Acceptance, and Regulatory Compliance issues
  • The position involves making decision involving all areas mentioned above. In some instances, there are written policies or procedures that have to be interpreted. In some instances, only judgment based on past experience can be used. Judgment is critical to interpret a wide variety of quality requirements and documents.  Critical to ensure only product available for release is release into commercial distribution.

Education and/or Experience

  • Four (4) year Science, Engineering, Technology or Business Degree.
  • Five (5) years experience in a decision-making quality position with at least four (4) years in FDA/ISO/OSHA/etc. regulated industry (pharmaceutical / medical device).
  • Four (4) years management experience in a quality management role.
  • Thorough knowledge of regulations governing production, packaging, inspection (preferably incoming/final release), testing and warehousing.

Physical Demands

Employee may be required to sit, bend, stoop, climb stairs, use keyboard, see, talk and hear.  May occasionally lift objects up to 30 lbs.  May involve use of Personal Protective Equipment (PPE) or other safety equipment/requirements, as specified by facility/environmental conditions.  On-call, overtime and/or weekend work may be required to support business needs.

 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

This position generally works in a controlled office environment.  Occasionally, the incumbent will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals.

 

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