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QC Engineer IV

Company: Analogic Corporation
Location: Peabody
Posted on: April 15, 2019

Job Description:

# of Openings

1

Category

Quality

Type

Regular Full-Time

OVERVIEW

Analogic provides leading-edge healthcare and security technology solutions to advance the practice of medicine and save lives. We are recognized around the world for advanced imaging systems and technology that enable computed tomography (CT), ultrasound, digital mammography, and magnetic resonance imaging (MRI), as well as automated threat detection for aviation security. For over 50 years we ve enabled customers to thrive, improving the health and ensuring the safety of people around the world. Analogic is headquartered north of Boston in Peabody, Massachusetts.



POSITION SUMMARY:

Plans, organizes and coordinates Quality Engineering and Inspection activities supporting manufacturing operations in conformance with the Analogic Quality Management System and in alignment with overall business strategies and company goals.

RESPONSIBILITIES

* Defines and implements standards, methods, and procedures for inspecting, testing, and evaluating the precision and accuracy of produced complex electro-mechanical products and raw materials.

* Trains and assists Quality resources as needed to resolve any technical challenges and reduce costs associated with yield, scrap, and rework of manufactured product and supplied components.

* Collaborates with other disciplines involved in the support of all manufacturing operations to ensure cohesive cross-functional Quality efforts and maintains close communication with all departments.

* Maintains Quality Metrics and prepares reports as needed on performance for use by Procurement, Quality, Engineering, and Management for trend analysis and improvements.

* Determines statistical indicators to reduce or eliminate redundant tests and inspections.

* Investigates production/material issues and recommends disposition and corrective actions.

* Performs process audits as needed for initial process qualification and improvement initiatives.

* Analyzes process capability limitations and recommends revision of procedures when appropriate.

* Works with Engineering, Manufacturing and Suppliers on Measurement Systems Analysis Studies to assure robust streamlined measurement systems where appropriate.

* Participates in design reviews during new product introduction promoting DfX philosophies.

* Facilitates root cause analyses to develop permanent irreversible corrective actions.

* Champions Lean/Six Sigma, CAPA, 5S, and other Quality Improvement projects.

* Supports factory inspections/audits by customers and regulatory agencies.

QUALIFICATIONS

EXPERIENCE:



* 5+ years related experience with electromechanical products desired.

* 2+ years additional related experience in the medical device industry preferred.

* Quality Engineering and Quality Management experience preferred.



COMPETENCIES:



* Ability to analyze, measure, develop, and maintain continuous improvement processes.

* Familiar with precision measurement and geometric dimensioning and tolerancing (GD&T).

* Understands electrical design principles, manufacturing standards, and test methodologies.

* Knowledge of ISO 9001, ISO 13485, ISO 14971 and/or ISO 12100 Risk Management, FDA-QSRs, 21CFR Part 820, and GMP QMS requirements.

* Working knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, PFMEA, Control Plans, Copy Exact Policies, etc.

* Performance/process metrics, Statistical Process Control (SPC), Six Sigma, Lean, DfX, Design of Experiments (DOE), 8D, Corrective and Preventive Action (CAPA), and complaint resolution.

* Excellent organizational, time management, conflict resolution and relationship building skills with the ability to motivate and influence others in support of cross-functional teams.

* Proficient with Word, Excel, PowerPoint, Access and Agile and SAP.

* Excellent interpersonal, verbal and written communication skills.

Keywords: Analogic Corporation, Peabody , QC Engineer IV, Engineering , Peabody, Massachusetts

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