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Posted: Saturday, March 11, 2017 3:22 PM

Job Description:/h3:
Austco is seeking a qualified QA Manager. Applicants must have experience with FDA.

JOB DESCRIPTION

Provide the leadership, strategic insight, direction, and implementation for all quality assurance activities resulting in continued product improvement and compliance
Provide the leadership, strategic insight, direction, and implementation for all quality assurance activities related to new product development, product improvement, and compliance
Staff and lead a proactive Quality
Assurance/Regulatory department
Coach and develop all staff in professional development to retain highest caliber team
Serve as the Management Representative for any quality system audits and coordinate regular reports to other members of the executive management team
Manage budgetary requirements and ensure compliance of expenditures to meet budget for worldwide programs
Be an effective team player interfacing well with R and D, Manufacturing Engineering, Manufacturing, Clinical, Marketing and Sales
Maintain a quality system that is compliant with FDA QSR and upgrade the existing quality system to be compliant with ISO 13485:2003 or any other international regulations needed for company objectives
Work with the company to continually improve quality system and procedures
Use quality science techniques such as voice of the customer, defect prevention, process capability studies, gage R and R, supplier process certification, etc. to improve product yields and reduce scrap
Establish metrics to measure the quality of products and processes
Lead and manage the development and deployment of a global regulatory program that ensures aggressive product adoption and meets corporate objectives within applicable regulations and guidelines
Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies
Set internal standards for and review all FDA submissions and foreign filings to ensure adequacy and regulatory accuracy
Perform other duties as required

CRITICAL REQUIREMENTS
Qualifications / Skills Required
BA/BS in Life Science, Bio:Medical Engineering or a related is preferred (advanced degree a plus) Minimum 10 years experience in management of quality assurance and regulatory activities for Class II medical devices.
Experience in implementing quality systems (FDA QSR and ISO 13485) in developing medical device companies.
Experience in successful management of relationships at all levels of the organization, including external relationships with FDA and suppliers
Experience in both software:controlled devices and devices with significant manufacturing processes preferred
Evidence of leadership and a management style characterized by vision, teamwork, preparation, communication and negotiation
Strong quality engineering skills in utilizing quality science techniques such as voice of the customer, defect prevention, process capability studies, and gage R and R
Proven in being a respected regulatory executive in the medical device industry and have an excellent working relationship with the FDA
Proven track record in developing validation protocols, process validation, inspection and test methods

Company Description:/h3:
Austco Communication Systems is a world leader in the highly specialized field of electronic emergency communications, nurse call, and clinical workflow management solutions that was established in 1985. Our product philosophy of superior reliability, innovation, functionality, and aesthetics has seen Austco grow from a small regional manufacturer in 1985 to a top international manufacturer today with systems installed in over 8,000+ facilities in 56 countries.

Source: https://www.tiptopjob.com/jobs/64599964_job.asp?source=backpage


• Location: North DFW

• Post ID: 48780718 northdfw
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