Quality Systems Engineer - Scarborough, ME, United States - GTT, LLC

GTT, LLC Scarborough, ME, United States

3 weeks ago

Temporary

Description

Quality Engineer
Contract Duration 3 Months

Manufacturing Line Quality Engineers operate as an independent Quality resource partnered with Production to facilitate GMP, GDP, and Client quality standard compliance.

Responsible for assisting in the implementation and maintenance of an effective Quality System for the site.
Responsible for performing line clearance, shift change activities, set-up verification, and label verification.

Independently contribute to Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, and validation.

Coach and reinforce quality attributes and requirements. M ay provide technical assistance.
Independently utilize quality management techniques to perform investigations and facilitate solutions.

Quality Engineer will be responsible for independently completing documentation in a timely manner and in accordance with business standards.

Responsible for maintaining the effectiveness of the Quality System.
Understand and comply with applicable EHS policies, procedures, and guidelines.

Works under the general supervision of more experienced staff who review results for overall accuracy, completeness, and sound judgment; identifies and quantifies technical risks and their consequences relative to the success of part of a project; decisions or recommendations would typically achieve department/project objectives; drives functional performance to ensure that cross-functional standards and expectations are met; may assist in the training of personnel as directed by management; Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to ensure compliance with client software development procedures and industry regulations.

Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis.

Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs.

Occasionally provide training for select software development activities for the client.
Bachelor's Degree (± 16 years)
An equivalent combination of education and work experience
Quality Engineer should possess the following:
Demonstrated technical competency and working technical knowledge and application of concepts, practices, and procedures;
Ability and aptitude to use various types of databases and other computer software;
strong organizational and project management skills; Medical, Vision, and Dental Insurance Plans
401k Retirement Fund

Our client is a globally diversified healthcare company with a central purpose of helping people live their healthiest possible lives.

They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets.

Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies.

They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love.

It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.

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