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Job description (Tasks/Responsibilities):
Work in support of product commercialization by serving as
QA department's representative on organizational development teams. Participate in organizational design activities including
FMEAs, FTAs, validation development and auditing. Support Product Design changes throughout the life of the
product. Assure changes comply with Design Control requirements. Responsible for developing and or reviewing key design
documentation including; quality assurance plans, design reviews, design verification
and validation plans, and technical files. Review and approval of change notices involving changes to
product configuration and introductions of new product configurations. Work in conjunction with Manufacturing QA to coordinate
and support quality assurance activities associated with product transfer into
production. Audit product Design History Files to ensure compliance
with company quality procedures, external standards and all regulatory
requirements as they apply to the Sleep and Home Respiratory Group Design
Control processes.
Skill Requirements:
BS in Engineering (Electrical or Mechanical preferred) or
related field. Minimum 3 to 5 years experience in medical device or other
related highly regulated industry. Demonstrated understanding of and experience with the FDA
Quality System Regulations and other relevant international quality standards
in the areas of design controls, production and process controls and purchasing
controls. Demonstrated understanding of and experience in applying
quality engineering concepts (statistical competency, acceptance sampling, DOE,
control and capability studies, FMEA). Experience with Codes of Federal Regulations (21 CFR, Part
801, 803, 806 & 820). Excellent technical writing, communication and
organizational skills required. ASQ Certified Quality Engineer is a plus. Experience with MS Office products required, experience
with statistical software is a plus. Ability to work independently and complete multiple
assignments on time.
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Company Description:
Respironics, a
worldwide leader at anticipating needs and providing valued solutions to the
sleep and respiratory markets. The company's focus is on home care, hospital, respiratory drug delivery and
international markets providing programs that manage sleep disordered
breathing, chronic obstructive pulmonary disease, asthma, infant care,
congestive heart failure and restrictive lung disorders. Globally positioned
has manufacturing facilities in several domestic and international markets.
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