Quality Control & Assurance
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Respiratory Motion, Inc.
Watertown, MA, USA
Job Posted:
30+ days ago

Quality Control & Assurance


Company: A medical device company, based in Waltham, MA, commercializing a respiration monitor for hospital use.

Description: The position will help manage and support the quality system in a medical device company.

Reports to: Quality Manager

Position Responsibilities:
Provide support in all areas of Respiratory Motion’s Quality Management System: CAPA, Training, Doc Control, Complaints, MRB/NCMR, Internal Audits and Management Reviews.
Manage the documentation required as part of the Quality System related to Manufacturing
Assist in the maintenance of supplier certification/performance measurement program data
Manage Receiving and Inspection of incoming materials
Assist in manufacturing processes and driving product quality
Other duties as required

0 - 5 years relevant work experience in a medical device environment
Pursuing, or recent graduate, of a related degree
Experience in a GMP/medical device environment with ISO 13485, FDA, Medical Device Directive 93/42/EEC, and CMDR (Canadian Medical Device Regulation) is preferred
Familiar with product specifications and incoming inspection procedures
Proven track record, must be organized, able to meet deadlines, and have a strong attention to detail
Knowledge of Quality Systems
Self-starter, able to work independently with the ability to manage multiple priorities
Analytical thinker with strong problem solving skills
Capable of streamlining, improving processes and troubleshooting
Solid communication skills; both verbal and written
Strong knowledge of MS Office and experience with customizing spreadsheets

Job Types: Full-time, Part-time, Internship
Salary: $15.00 to $18.00 /hour

Quality Systems, Quality Control, Medical Device, Manufacturing, Quality Assurance