QA – CLEANROOM INSPECTOR – 2ND SHIFT Position Available In Plymouth, Massachusetts

QA•CLEANROOM

INSPECTOR

•2ND SHIFT Primo Medical Group•2.5

West Bridgewater, MA Job Details Full-time Estimated:

$41.5K•$49.3K a year 1 day ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance Life insurance Qualifications Basic math Calipers Quality management Mid-level Microsoft Office 3 years High school diploma or GED Quality assurance Micrometer Cleanroom Manufacturing

ISO 13485 FDA

regulations Full Job Description

QA CLEANROOM INSPECTOR

2nd SHIFT•STOUGHTON

MA BE A PART OF OUR AMAZING TEAM!

! Primo Medical Group ,Inc. is searching for a Quality Cleanroom Inspector to join our team! We are a leader in the development of medical devices and precision machined components. Primo is a dynamic, innovative company offering competitive salary, excellent benefits and has a strong focus on the training and professional advancement of its employees.

Essential Duties and Responsibilities:

Reads and understands all Quality Management System procedures related to the position / function within the organization. Performs incoming, First Piece, in-process and final inspection per relevant specifications. Documents the results of these inspections on the appropriate Quality Plans. Prepares Nonconforming Material Reports (NCMR) and Customer Deviation Requests (CDR) as applicable for discrepant materials and components. Maintain accurate records within the Quality Assurance Database for inspection results and nonconforming material handling. Review and approve material and special process certifications. Prepares required documentation for finished product final release. Performs inspections of all labeling and instructions included with finished medical devices. Reviews all products requiring sterilization prior to the activity to ensure that product is approved for the designated sterilization process and the proper dose / cycle is specified. Reviews all products returning from sterilization to ensure that the proper dose / cycle was applied and certification is complete and correct. Ensures that no sterile product is shipped without the proper authorizations. No sterile product is released for distribution without written customer release / authorization. Reviews and releases for distribution, sterile product from

Customer Inventory Quality Cleanroom Inspector Requirements:

High School Diploma or equivalent. Minimum three (3) years experience in manufacturing or quality assurance (or equivalent combination of education and experience). Working knowledge of

FDA 21CFR820

Quality System Regulations (QSR) and

ISO 13485

Quality Management Systems. Experience and/or training in Cleanroom Operations a plus. Must posses experience with instruments and tools such as Micrometers, calipers, comparators and vision systems. Must have the ability to work with basic mathematical concepts and problem solve utilizing a commonsense approach. Must possess ability to read and interpret technical drawings and specifications in addition to the ability to write reports and answer questions from managers, employees and suppliers. Must posses the ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

We Offer:

Competitive compensation Excellent benefits Professional Growth Assistance Primo Medical Group, Inc. is an Equal Opportunity Employer and ay offer reasonable accommodation to enable individuals with disabilities to perform the essential functions of the position.

Job Type:

Full-time Expected hours: 40 per week

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Schedule:

8 hour shift Monday to Friday Ability to

Commute:

West Bridgewater, MA 02379 (Required)

Work Location:

In person