QLTY & RELIABILITY ENGINEER II

Job Overview

The Quality Engineer oversees Operations Quality within their prescribed area of functional responsibility and will be working as part of a team to maintain high quality / performance standards on all Creganna Medical products. 
The Quality Engineer reports to the Supervisor of Quality Engineering, the Operations Quality Engineer is a member of the Operations Quality group.

Responsibilities:
· TE Connectivity's Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors.
· Our teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary.
· This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the Creganna Medical Quality System.
· The focus of the role is to supply high quality medical devices and components to deliver an Extraordinary Customer Experience.
· The Quality Engineer oversees Quality within their prescribed area of functional responsibility and will be working as part of a team to maintain high quality / performance standards on all Creganna Medical products.
· The Quality Engineer reports to the Supervisor of Quality Engineering, the Operations Quality Engineer is a member of the Operations Quality group.
· Works with the area supervisor and manufacturing engineering to promote the achievement of the Health and Safety goals.
· To deliver on all KPIs that help the business achieve its goals.
· The quality engineer will perform an active role in further development and continuous improvement of the quality management system.
· Establish and maintain risk management principles and methods throughout the product realization process in compliance with the company's Quality Management system and ISO 14971.
· Maintain relevant documentation to comply with quality standards and customer requirements.
· Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations.
· Develop strong links with customer organizations and other project stakeholders.
· Quality review of responsible area validation documentation.
· Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.
· Overall responsibility for production GMP standards and compliance.
· Establishing inspection standards, sampling plans and test methods.
· Read engineering drawings interpreting Geometric Tolerancing and develop the corresponding quality inspection plans (QIP) for components and assemblies.
· Read and interpret quality specifications and requirements.
· Collect statistical data using programs such as Minitab or JMP
· Prepare reports and present to engineering team.
· Be a resource for design of experiments (DOE) and capability studies.
· Execution of failure analysis (Ishikawa, 5 Why, 8D).
· Analysis of quality and process data (ppm, scrap, Pareto, CPK, COPQ etc.).
· Preparing and updating Operations procedures and associated documentation, as needed.
· Oversee customer audits and surveillance / accreditation audits, as needed.
· Conducting audits of the manufacturing operation and the Quality system ensuring compliance with ISO13485, as needed.
· Support Operations area projects and initiatives, as needed.
 
 

What your background should look like:

Qualifications:

• 3 or more years of experience in Quality or Reliability Engineering, 3+yrs industry experience in a medical device-manufacturing or pharmaceutical environment. (Preferred but not required)
• Bachelor’s degree in engineering, Quality, or related technical field (Preferred but not required)
• Ability to demonstrate expertise in quality tools, practices, and procedures.
• Strong organization, interpersonal and communication skills are required.
• Excellent written and oral communication skills essential.
• Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies preferably ISO 13485 & ISO 14971.
• Process control knowledge and implementation experience (pFMEA, SPC, CPK, Gage R & R, Control Plans, etc.)
• Worked in a team environment providing assistance to various departments requiring consistent quality assurance systems to succeed.
• Strong computer skills with proficiency in Microsoft Excel, Word, PowerPoint and statistical software packages (i.e., Minitab).

Competencies