Senior Mechanical Inspector

Primo Medical Group; Stoughton, Northern (MA, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Primo Medical Group in Massachusetts is seeking a Senior Mechanical Inspector to lead incoming, in-process and final inspections of medical devices and precision machined components. You will mentor junior staff and ensure inspection methods meet QMS requirements.

Responsibilities include setting up and programming CMM and RAM systems, documenting results, preparing NCMR/CDR, and maintaining QA records. You will review material certifications and participate in device history reviews to support

Qualifications

• High School diploma or equivalent with 10+ years in Manufacturing or Quality Assurance.
• Experience with GD&T, FDA 21CFR820 QSR, and ISO 13485 Quality Management Systems.
• Proficient in reading blueprints and specifications; skilled with inspection instruments.

Responsibilities

• Read and interpret quality procedures and specifications.
• Perform incoming, in-process, and final inspections and document results.
• Set up and program CMM and RAM systems.
• Prepare Nonconforming Material Reports (NCMR) and Customer Deviation Requests (CDR).
• Maintain QA records and review material certifications and device history records.

Skills

Blueprint interpretation

Dimensional inspection

Detail orientation

Problem solving

Quality mindset

Education

High School diploma or equivalent

Tools

CMM

RAM systems

Micrometers

Calipers

2D/3D measurement tools

ERP system

QA Database

Microsoft Office

Adobe Acrobat

Job description

Primo Medical Group. is searching for a Senior Mechanical 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.

Senior Mechanical Inspector

The Senior Mechanical Inspector will perform all aspects of Incoming, In-process and Final Inspection of materials, components and finished medical products. Mentors less experienced inspectors and operators in proper inspection methods and techniques. The Senior Mechanical Inspector performs the following duties:

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.
• Sets up and programs advanced inspection equipment such as the CMM and RAM systems.
• 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.
• Reviews and releases for distribution, sterile product from Customer Inventory.
• Review and verify Device History Records to ensure that all required documents are present, complete and accurate prior to scanning them into the Document Control System.
• Execute protocols and support Engineering on special projects such as Gage R&R and Component Qualification.
• Ensure that the Quality Assurance philosophy is disseminated to suppliers and personnel within the organization.
• Maintain a working knowledge of industry Quality Assurance standards.

Supervisory Responsibilities

This position has no direct supervisory responsibilities

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

High School diploma or equivalent and ten years’ minimum experience in a Manufacturing or Quality Assurance environment. Working knowledge of Y14.5 Geometric Dimensioning and Tolerancing (GD&T), FDA 21CFR820 Quality System Regulations (QSR) and ISO 13485 Quality Management Systems.

Excellent Blueprint / Specification reading / interpretation skills. Experience in the proper use of the following instruments and tools:

Micrometers, calipers, thread gages and similar manual instruments,
Surface-plate set-ups, Micro-Hites, drop indicators
Coordinate Measuring Machines
Non-contact instruments such as comparators and vision systems.
Reasoning Ability

Ability to read and interpret technical drawings and specifications.
Ability to write reports and business correspondence.
Ability to effectively present information and respond to questions from managers, employees and suppliers.

Mathematical Skills

Ability to work with basic mathematical concepts

Reasoning Ability

Ability to solve practical problems using a commonsense approach.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Attention to detail.

Physical Ability

20/20 corrected vision and / or ability to distinguish colors, see fine imperfection and flaws

Computer Skills

Individual should have a good working knowledge of the elements within the current E.R.P. system, the QA Database, Microsoft Office and Adobe Acrobat.