Quality Assurance Director
C. R. Bard - Humacao Municipio, PR

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Manages the Quality Assurance department. Serves as a member of the Plant Management Staff. Serves as the Management Representative for the BPR Quality System.
Responsible for the management of all plant quality functions including Quality Engineering, Quality Control, Document Control, Sterilization, Field Assurance, Failure Investigation and GMP Auditing and Supplier Management. Develops and drives the QA strategy in support of BPR Plant goals and business initiatives. Provides quality system support for the NPD and Technology transfers. Manages QC operations for existing products. Oversees the preparation and integrity of data for the purpose of CAPA management, failure investigations, process validations, complaint investigations, and manufacturing process improvements. Serves as the primary plant interface with FDA & global regulatory notified bodies to assure compliance with applicable quality systems and GMP requirements.

Summary of Position with General Responsibilities:
Manages the Quality Assurance department. Serves as a member of the Plant Management Staff. Serves as the Management Representative for the BPR Quality System.
Responsible for the management of all plant quality functions including Quality Engineering, Quality Control, Document Control, Sterilization, Field Assurance, Failure Investigation and GMP Auditing and Supplier Management. Develops and drives the QA strategy in support of BPR Plant goals and business initiatives. Provides quality system support for the NPD and Technology transfers. Manages QC operations for existing products. Oversees the preparation and integrity of data for the purpose of CAPA management, failure investigations, process validations, complaint investigations, and manufacturing process improvements. Serves as the primary plant interface with FDA & global regulatory notified bodies to assure compliance with applicable quality systems and GMP requirements.

Essential Job Functions:
Develops quality policies, goals, objectives, and executive reports
Establishes effective quality procedures and project plans for each NPD and technology transfer projects to ensure that FDA, Corporate and global quality system requirements are met
Lead multi-departmental teams to implement the quality strategies with respect to the collection, documentation, analysis, and reporting of quality data for the purposes of management review
Communicates to BPR Management on the status and performance of the BPR quality system
Review and approve product releases
Consults with Corporate and Division QA management to determine Health Hazard Evaluations associated with Failure Investigations and Subject Product Analyses
Acts as liaison between BPR, the FDA, and other international regulatory bodies, during GMP and quality systems audits
Oversee and/or prepare appropriate responses and/or corrective action plans to any FDA Form 483 observation
Coordinates on all plant related activities for product remedial action plans
Formulate and implement annual department goals, action plans, and budgets according to plant and departmental priorities
Review complaint reporting and trend analysis to monitor field activity, to formulate corrective action feedback with to appropriate plant and division personnel

Assures is trained before performing any task
Uses the required clothes and personal safety protective equipment according to operations requirements
Complies with cGMP’s, Quality Standards and established policies and/or procedures
Executes other duties assigned by Supervisor

Basic Qualifications:
  • Working knowledge of US FDA and International regulations governing the medical device industry, i.e., QSR, GMP, MDR, and ISO 13485: 2003
  • Strong managerial skills and ability to manage departmental budgets
  • Excellent problem solving skills
  • Knowledge of fundamental quality systems principles such as CAPA, Failure Investigation, Process Validation, Supplier Management, QC test and inspection
  • Leadership and people development skills
  • Must be bilingual (English/Spanish) and must have good communication skills both oral and written
  • Team work oriented.
Additional Desirable Qualifications Skills and Knowledge:
ASQ Engineer certification desired.

Education and/or Experience:
B.S. degree in Engineering, Microbiology, Chemistry or related scientific field required. M.S., M.B.A., or advanced degree highly recommended
Eight (8) or more years experience in managing QA programs in the medical device industry

Physical Demands:
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT

1. Frequency and percentage of a day the worker is required to do the following specific types of activities:
ACTIVITY
FREQUENCY
% OF A DAY

CONTINUOUS
INTERMITTENT
10
20
30
40
50
60
70
80
90
a. Walking

X

X

b. Standing

X
X

c. Stooping

N/A

d. Squatting

N/A

e. Climbing

N/A

f. Kneeling

N/A

g. Twisting

N/A

i. Lifting

N/A

j. Sitting

N/A

X

X

LIFTING
0-10 lbs. 10-20 lbs. 20-30 lbs. 30-50 lbs. Over 50 lbs.

2a. HAND MANIPULATION REQUIRED? ______Yes (If yes, complete a,b,c,d,e) ___X__ No

2b. Repetitive hand movements? _____Yes _____ No
2c. Simple Grasping?
Right Hand_____
Yes_____ No_____
Left Hand_____
Yes_____ No_____

2d. Power Grasping?

Right Hand_____
Yes_____ No_____

Left Hand_____
Yes______ No_____

2e. Pushing /Pulling?
Right Hand_____
Yes_____ No_____
Left Hand_____
Yes______ No______

2f. Fine manipulation:
Right Hand_____
Yes_____ No_____
Left Hand_____
Yes______ No_____

C. R. Bard - 18 months ago - save job - block
About this company
8 reviews
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...