Qualifications:
Limited/Basic application of Quality systems principles and concepts (e.g. Document control, Complaint Mgt or other broad Quality Systems area).
• Limited knowledge of applicable Regulatory, Corporate and/or Unit requirements.
• Strong skills in MS applications (Word, Excel, PowerPoint, Visio, Project) required.
• Strong communication skills and attention to detail.
• Strong organizational skills and demonstrated ability to meet tight deadlines in an environment of competing priorities.
• Data entry skills.
• Associate Degree or Bachelor Degree is preferred but not required.
Responsibilities:
• As directed by the Quality Manager, the Quality System Specialist I is accountable for support of the continued development, improvement and implementation of the Quality Systems.
• This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities.
• Performing tasks, of moderate complexity, within planned schedules and timelines, supporting audits, actively leading or participating on project teams, ensuring documentation compliance, and handling customer complaint investigation/resolution Complaint data entry Develops solutions to routine assigned activities of limited scope (e.g. Document change, Complaint file entry, CAPA documentation
• Prepares basic reports and summaries, including quantitative and qualitative analysis Uses standard and approved Quality/Compliance methods ( Good Documentation practices) Prepares basic reports and summaries, including quantitative and qualitative analysis Follow applicable Company, Business unit policies and procedures Work is closely supervised Develops solutions to routine assigned activities of limited scope
Limited/Basic application of Quality systems principles and concepts (e.g. Document control, Complaint Mgt or other broad Quality Systems area).
• Limited knowledge of applicable Regulatory, Corporate and/or Unit requirements.
• Strong skills in MS applications (Word, Excel, PowerPoint, Visio, Project) required.
• Strong communication skills and attention to detail.
• Strong organizational skills and demonstrated ability to meet tight deadlines in an environment of competing priorities.
• Data entry skills.
• Associate Degree or Bachelor Degree is preferred but not required.
Responsibilities:
• As directed by the Quality Manager, the Quality System Specialist I is accountable for support of the continued development, improvement and implementation of the Quality Systems.
• This position actively participates in quality guidance, product resolution decisions and statistical problem solving techniques to New Product Development and project teams for process improvement and continuous improvement activities.
• Performing tasks, of moderate complexity, within planned schedules and timelines, supporting audits, actively leading or participating on project teams, ensuring documentation compliance, and handling customer complaint investigation/resolution Complaint data entry Develops solutions to routine assigned activities of limited scope (e.g. Document change, Complaint file entry, CAPA documentation
• Prepares basic reports and summaries, including quantitative and qualitative analysis Uses standard and approved Quality/Compliance methods ( Good Documentation practices) Prepares basic reports and summaries, including quantitative and qualitative analysis Follow applicable Company, Business unit policies and procedures Work is closely supervised Develops solutions to routine assigned activities of limited scope