QC Engineer IV
Company: Analogic Corporation
Posted on: April 15, 2019
# of Openings
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.
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.
* 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
* 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
* Champions Lean/Six Sigma, CAPA, 5S, and other Quality Improvement
* Supports factory inspections/audits by customers and regulatory
* 5+ years related experience with electromechanical products
* 2+ years additional related experience in the medical device
* Quality Engineering and Quality Management experience
* Ability to analyze, measure, develop, and maintain continuous
* 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
* Excellent interpersonal, verbal and written communication skills.
Keywords: Analogic Corporation, Peabody , QC Engineer IV, Engineering , Peabody, Massachusetts
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