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Quality Auditor

The Building Performance Institute (BPI) is seeking the part-time services of a 

Certified Quality Auditor or equivalent to provide quality assurance services in 

western New York.  Successful candidates will be responsible for collecting key 

information from the job records of contractors who are participating in BPI’s 

Accreditation program.  More information on the accreditation is available at 

www.bpi.org/documents/guidetoAccreditation.pdf. 

It is not required that the successful candidate hold BPI’s building analyst certification 

in order to conduct the necessary office records reviews, as the required field measurement

 and verification activities will be conducted separately by individuals holding at a minimum 

the Building Analyst designation.  The primary geographic areas are Buffalo, Rochester, and 

Syracuse, although Albany (Malta) and other New York State locations are needed.

 

 

Larry Zarker

Chief Executive Officer

Building Performance Institute, Inc.

Washington, DC Office

Takoma Metro Center, Box 5242

Takoma Park, MD   20913

(301) 270-4906 (o)

(202) 256-3893 (c)

lzarker@bpi.org

www.BPI.org

 

 

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OPPORTUNITY: Quality Manager (Rockport, MA) COMPANY: Small medical device manufacturer of LIM/LSR injection molded products. Reports directly to the VP/Gen Mgr as the Management Representative and has overall responsibility for all aspects of the quality management system and quality control areas. Also reports on dotted line to Corp Dir of QA DUTIES: · Manages the day to day and long term activities of the quality department. · Coordinate FDA regulations. Coordinate ISO 9001 & implement ISO13485 systems. · Interfaces with customers and suppliers about problems and establishing standards. · Prepares reports required for the Management Review Meetings. · Is responsible for monthly metrics on delivery performance and customer complaints. · Reviews and approves all quality system and manufacturing related documents. · In conjunction with the Office Manager, is responsible for having contract reviews performed for all customer purchase orders. · Prepares, completes and publishes the Internal Audit schedules and ensuring they are accurate. · Performs quality planning for incoming, in-process and final acceptance using customers’ requirements (if available). · Overall responsibility for the corrective and preventive action programs, calibration/metrology program and control of documents. REQUIREMENTS: · 4 degree-BS/BA · Must have 5-10 or more years experience in managing quality assurance and quality control departments in a medical products or thermoplastic products manufacturing facility. · Must have a background in quality management systems with FDA & ISO standards: 1. ISO ISO 13485:2003 – Quality Systems – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. 2. ISO 14969:2004 – Medical Devices – Quality Management Systems- Guidance on the application of ISO 13485:2003 3. ISO 14971:2000-and 1; 2003; Medical Devices – Application of Risk Management to Medical Devices. · Excellent verbal, written, organizational and planning skills. · Ability to lead training requirements. Send updated resume to cblack@jrsconsultants.net. Provide your availability and desired compensation. Thank you, Caprice Black Executive Recruiter JRS Consultants LLC 234-380-1185 (Office) 330-592-6566 (cell) cblack@jrsconsultants.net