Field Assurance (Quality) Manager Job in Tempe, AZ 85282
Title :
Field Assurance (Quality) Manager
Company :
C. R. Bard
Location :
Tempe, AZ 85282
Date Acquired :
2/24/2010 1:21:58 AM
Field Assurance (Quality) Manager
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: Medical Device/Quality
Job ID: 2010-4161
Standard Title: Field Assurance (Quality) Manager
Career Level: management
Location/Division: Tempe/BPV
Relocation: Yes
Posted Date: 2/23/2010
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Overview:
Bard Peripheral Vascular, located in Tempe, AZ where a tradition of vascular innovation spans decades of focusing on improving the quality of patients lives.
From C. R. Bards first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists.
Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce
Summary of Position with General Responsibilities:
This individual is responsible to ensure that the BPV complaint handling process complies with all the Regulatory requirements and Bard Corporate Standards. Provide BPV management with unfavorable trends in complaints. Establish, maintain and update Field Assurance procedures. Interface with external customers in a professional manner. This individual will lead the Field Assurance team and provide direction.
Essential Job Functions:
Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.
Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division needs.
Interface with internal and external customers with regard to finished product quality issues and customer dissatisfaction.
Assure BPV’s complaint handling system complies with current US FDA/International regulations and Bard’s corporate standards and guidelines.
Ensure all reportable events are done accurately and in a timely manner – complying with Regulatory and BPV timelines.
Evaluates complaints for determining MDR/Vigilance events and documents rationale for not filing MDRs.
Review and analyze complaint trending, failure modes and advise BPV Management when and as appropriate.
Assure distribution agreements and quality contracts meet complaint handling requirements in BPV’s best interests.
Report trending on complaints to the appropriate product assessment teams (PAT) when and as appropriate.
Collaborate with design teams and Quality Engineering to investigate and evaluate appropriate product enhancements and assessing risk profiles for the new products.
Assist in Regulatory, 3rd party and corporate audits.
Benchmark best practices within Bard and externally for complaint management process.
Responsible for promoting a positive “teamwork’ environment within the department.
Perform other duties at the direction of the department head.
Basic Qualifications:
A working knowledge of and practical experience with the FDA Quality System Regulations and Guidelines, Medical Device Directives, associated harmonized standards, ISO 13485, and related quality standards.
Computer proficiency with the standard software programs, i.e. Microsoft Word, Excel, TrackWise, QUMAS.
Working knowledge and understanding of statistical methods and analysis.
Strong organizational and problem solving skills.
Excellent communication skills, both written and oral.
Ability to interact effectively with internal and external customers ensuring a positive work environment while providing the necessary support.
Education and/or Experience:
BA or BS Degree in Science or Engineering or equivalent.
Must have 8 years of medial device experience (class II/Class III)
3 – 5 years of managerial experience preferred.
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: Medical Device/Quality
Job ID: 2010-4161
Standard Title: Field Assurance (Quality) Manager
Career Level: management
Location/Division: Tempe/BPV
Relocation: Yes
Posted Date: 2/23/2010
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Overview:
Bard Peripheral Vascular, located in Tempe, AZ where a tradition of vascular innovation spans decades of focusing on improving the quality of patients lives.
From C. R. Bards first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists.
Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce
Summary of Position with General Responsibilities:
This individual is responsible to ensure that the BPV complaint handling process complies with all the Regulatory requirements and Bard Corporate Standards. Provide BPV management with unfavorable trends in complaints. Establish, maintain and update Field Assurance procedures. Interface with external customers in a professional manner. This individual will lead the Field Assurance team and provide direction.
Essential Job Functions:
Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.
Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division needs.
Interface with internal and external customers with regard to finished product quality issues and customer dissatisfaction.
Assure BPV’s complaint handling system complies with current US FDA/International regulations and Bard’s corporate standards and guidelines.
Ensure all reportable events are done accurately and in a timely manner – complying with Regulatory and BPV timelines.
Evaluates complaints for determining MDR/Vigilance events and documents rationale for not filing MDRs.
Review and analyze complaint trending, failure modes and advise BPV Management when and as appropriate.
Assure distribution agreements and quality contracts meet complaint handling requirements in BPV’s best interests.
Report trending on complaints to the appropriate product assessment teams (PAT) when and as appropriate.
Collaborate with design teams and Quality Engineering to investigate and evaluate appropriate product enhancements and assessing risk profiles for the new products.
Assist in Regulatory, 3rd party and corporate audits.
Benchmark best practices within Bard and externally for complaint management process.
Responsible for promoting a positive “teamwork’ environment within the department.
Perform other duties at the direction of the department head.
Basic Qualifications:
A working knowledge of and practical experience with the FDA Quality System Regulations and Guidelines, Medical Device Directives, associated harmonized standards, ISO 13485, and related quality standards.
Computer proficiency with the standard software programs, i.e. Microsoft Word, Excel, TrackWise, QUMAS.
Working knowledge and understanding of statistical methods and analysis.
Strong organizational and problem solving skills.
Excellent communication skills, both written and oral.
Ability to interact effectively with internal and external customers ensuring a positive work environment while providing the necessary support.
Education and/or Experience:
BA or BS Degree in Science or Engineering or equivalent.
Must have 8 years of medial device experience (class II/Class III)
3 – 5 years of managerial experience preferred.
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
