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Job description (Tasks/Responsibilities):
Direct responsibility for leading the incoming inspection,
nonconforming material, and product return activities. Direct supervisory responsibility for associates within
those areas. Maintain quality system compliance through leadership and
direction provided to direct staff and support offered to other departments. Direct and coordinate resources for projects which may
include systemic Quality System and distribution related process improvements
as well as corrective and preventive action support. Be responsible for the personal development of the QA team
with respect to training, performance management, and application of
organizational policies and procedures. Be responsible for overtime authorization, hiring,
administering disciplinary action as necessary, timecard approval. Make staffing recommendations and implementing staffing
plans along with providing input to and operating within the departmental
budget. Support the QA Department through involvement in special projects as
directed. Work closely with all manufacturing facilities within
Respironics on matters such as: delivery holds, new inspection needs, special
projects, corrective actions, shelf life requirements of products. Support the development and output of QA departmental
reporting metrics. Strive for continuous improvement, be team oriented,
communicate suggestions and concerns, generate solutions, be flexible, and
provide positive interaction and feedback with peers and internal departments.
Skill Requirements:
B.S. or equivalent in engineering, life sciences, or
technical field. Minimum of 5 years working as a team leader, project leader,
project manager or supervisor. Strong organizational and administrative skills, team
leadership and project leadership skills, written and oral communication
skills. Experience in a quality assurance function with working
knowledge of the FDA QSR and ISO 13485 and other regulations and international
standards. Strong working knowledge of inspection processes and
applicable standards. Broad experience in Microsoft Office programs, word
processing and spreadsheet applications required. Prior experience in the development and administration of
training programs, experience in SAP functionality, process and quality system
auditing is preferred.
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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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