The Associate Quality Engineering Director is location at C.R. Bard Medical Division in Covington, Georgia.
Summary of Position with General Responsibilities:
The Associate Quality Engineering Director has the responsibility of leading a directed R&D quality function (GLP, GCP, and/or GMP) to assure compliance and approval of new products as
measured by acceptance of all data/studies by the applicable regulatory authorities. The
primary objective of this position is to assure quality is designed into new products. This
includes direct responsible for effective oversight of regulatory inspections, departmental
systems, staff development, and personnel performance maintenance.
Essential Job Functions:
Define, lead and implement quality engineering in the design and development of
products, and in transfer and steady state phases of manufacturing operations.
Develop and improve quality systems to facilitate business and quality objectives:
o Ensure timely independent quality assessment of systems, reports, internal/external
facilities and documents that meet the company standard for quality and format.
o Resolution process to ensure the organization is alerted to issues in time to resolve
potential adverse affects on the customer, company or business.
compliance with Bard, government regulations and international standards
- Lead NPD Quality Engineering to support quality system design and implementation for
design plans and approving qualifications and validations. Support licenses and
- Support product development by preparing quality and reliability plans, reviewing
acquisitions by investigating levels of compliance, quality and reliability of potential
technologies and/or companies (due diligence).
compliance audits associated with GLP, GCP and/or GMP requirements in the Research
- Managing project and company risks.
- Oversee the analyses, evaluation, and presentation of information concerning NPD
and Development arena.
- Communicate business related issues or opportunities to next management level.
- Lead in Compliance to Design Control requirements.
Additional Desirable Qualifications Skills and Knowledge:
- Technical writing, budgeting, computer and management skills.
- Must have a proven track record in NPD Quality Engineering management including successful product launches.
- Knowledge and understanding of Document Control practices.
- Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.
- Comprehensive knowledge of quality systems and relationship to business.
- Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
- Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.
- Broad knowledge of manufacturing processes.
- Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
- Understands Fundamentals of Engineering Principles.
- Ability to effectively manage time and handle multiple task assignments..
- Ability to translate quality requirements into product specifications.
- Ability to interpret Regulations, Corporate, Division and Department Procedures.
College level mathematical skills.
Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology.
Able to take theoretical mathematics and apply to business problems.
Education and/or Experience:
- B.S. in Engineering or other applicable technical field. MS or Advanced degree highly recommended.
- Must have 10 years of Quality System (QSR and ISO 13485:2003) management
Regulations – ASQC certified engineer required.
- Must have at least 8 years experience with Industrial EO Sterilization of medical devices
- Must have 8+ years of managerial/leadership experience
- Working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable
The physical demands here are representative of those that must be met by an
employee to successfully perform the essential functions of this job. Reasonable
accommodations may be made to enable individuals with disabilities to perform the
essential functions. While performing the duties of this job, the employee is regularly
required to sit and talk and hear. The employee is occasionally required to stand, walk,
reach with hands and arms and lift and/or move up to 25 pounds. The employee is
required to withstand the normal rigors of short and long travel situations and meet with
other personnel in various areas of the building. Specific vision abilities required by this
job include close vision and distant vision.
C. R. Bard - 19 months ago
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...