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Posted: Sunday, May 21, 2017 12:07 AM

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About the Job


Qualifications: Bachelor’s degree with a major in Science or Engineering preferred. Experience in the Medical Device industry with an understanding of the FDA CGMP’s is required. Experience and knowledge of medical device Quality System Regulations and ISO Standards.


Essential experience and skills:



Quality orientation and high attention to detail.

Excellent interpersonal and communication skills.

Problem analysis and problem resolution skills.

General knowledge of quality management systems and manufacturing processes.

Willingness to learn.


Essential Duties and Responsibilities:


The Quality Engineer will ensure that processes needed for the quality management system are established, implemented and maintained. Will report to top management on the performance of the quality management system and any need for improvement. Will ensure the promotion of awareness of regulatory and customer requirements throughout the organization. Lead focused Quality projects or events as required, to resolve problems or make improvements to specific processes. Oversee inspections and final product release.


Duties and Responsibilities also include:



Develop and maintain QSR compliant processes which control the quality of parts and product throughout the procurement and production cycle.

Review results of tests and inspections in DHR or Receiving Inspection History Record.

Must know, facilitate and implement a quality policy that maintains compliance with applicable Quality System Regulations and ISO standards.

Actively lead or assist activities in the following areas: Incoming Inspection, Non-Conforming material, CAPA (Corrective and Preventive Actions), Production support, Document Control, Quality Management Reviews, Quality Audits, DHRs, Product Complaints and other associated tasks.

Work with suppliers, and Production Support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality is monitored and maintained.

Ensure that the Quality System is in compliance with all Regulatory and Quality System requirements.

Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc).

Participate in conducting internal/vendor audits.

Monitor Controlled environment manufacturing areas

Co-ordinate contract sterilization activities




Job Type: Full-time Required Education: Bachelor of Science



Send Resume to:

ACRA-CUT Inc.

989 Main Street

Acton, MA 01720

laubert@acracut.com


• Location: Boston

• Post ID: 39048501 boston
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