Manufacturing Line Quality Engineers operate as an independent Quality resource partnered with Production to facilitate GMP, GDP.
Responsible for assisting in the implementation and maintenance of an effective Quality System for the site.
Job Description
Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan 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 LifeScan.
Occasionally write and execute test protocols and reports.
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, validation.
Coach and reinforce quality attributes and requirements. May provide technical assistance.
Independently utilize quality management techniques to perform investigations and facilitate solutions.
Responsible for independently completing documentation in a timely manner and in accordance with business standards.
Responsible for maintaining the effectiveness of the Quality System.
Other tasks and duties as assigned.
Understand and comply with applicable EHS policies, procedures and guidelines.
Works under 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; recommends appropriate action; 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; may mentor others.
Qualification
Minimum 2 years
Bachelors Degree -an equivalent combination of education and work experience
Masters Degree
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Hospitals and Health Care
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