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Permanent

Hybrid

Quality Operations Specialist, Medical Device

Recruiter: Chris Coulter

Boston, MA

Job ID

01760

Industry

Regulatory

Specialty

Quality Assurance & Compliance

Experience level

Intermediate

Salary range:

$87,000 - $93,000

OVERVIEW

The Quality Operations Specialist will be part of an ever-expanding quality organization contributing to the quality and overall success to ensure both customers’ and patients’ needs are met, and that devices released to the market are conforming to specification. The Quality Operations Specialist position focuses on support, maintenance, and improvement of quality operations.

QUALIFICATIONS

BS in engineering discipline (Mechanical, Biomedical, Materials Engineering preferred) or related field required.

Experience using an electronic ERP system preferred.

Minimum two years Medical Device manufacturing industry experience required, with at least one year in Quality Assurance or Quality Operations preferred.

Operation under 21CFR820 Quality System Regulations required.

Familiarity with ISO 13485 preferred.

Strong communication skills, oral and written. This position interacts with suppliers, contractors, and other entities.

Ability to organize and prioritize multiple projects.

Data management and analysis experience is preferred.

Must function well both as a solo-contributor as well as part of a Project Team.

KEY RESPONSIBILITIES

Product acceptance activities, including DHR Review and Incoming Inspection

Quality inspections relating to servicing of medical device products, including Preventive Maintenance

Nonconformance handling

Support of Corrective and Preventive Action (CAPA) Investigations, Action Planning, and Action Implementation

Qualification and monitoring of production equipment, including managing calibration services

Creation, implementation, maintenance, and continuous improvement of quality system processes and procedures.

845-290-1900

845-357-3355

info@merraine.com

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