Product Quality Continous Improvement leader

GE Healthcare Umeå / Maskiningenjörsjobb / Umeå
2018-10-18
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The Product Quality Continuous Improvement leader will report into the QA organization and closely partner with site operations to drive product quality & process improvements resulting from internal & external data insights. This role with represent the voice of the customer within the customer feedback/complaint process & CAPA process, & be responsible for coaching members on RCA investigations & influencing/leading Product Quality & process improvements priorities.

Essential Responsibilities:
• Drive Product Quality & Production Process & service control Improvement priorities based on trends from internal & external product quality data in a timely maner
• Coach/SME to X-functional members on RCA/CAPA process & process improvement tools
• Create & Lead X-functional teams to support with Product Quality Improvement priorities
• Review and approve documentation supporting investigations such as RCA, V&V protocols/reports, Risk assessments, technical reports etc.
• Responsible for supporting report-outs to business leadership on improvements activity execution & performance

Qualifications/Requirements:
• Bachelor's degree in engineering or quality/health sciences field; and/or strong leadership experience in a Quality or Regulatory Assurance related field
• Aware of and comply with the GEHC ISO 9001 Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Demonstrated experience leading product quality complaints and compliant resolution in a timely manor, including customer interactions
• Demonstrated ability to lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions on data presented to support complaint resolution
• Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio

If you have any questions regarding the opening, please contact hiring manager Claire Lloyd, +44 2920 526710.
Last day of application is October 26th 2018.

Desired Characteristics:
• Product-specific knowledge in biomanufacturing Hardware & Software
• Experience of cGMP requirements &/or ISO 13485
• Demonstrated project/program management skills
• Demonstrated experience at effectively communicating within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies (i.e 6 Sigma/DMAIC) & in-depth understanding of site level products & related processes

Publiceringsdatum
2018-10-18

Så ansöker du
Sista dag att ansöka är 2018-10-26
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Företag
GE Healthcare Umeå

Kontorsadress
Mariehemsvägen 212

Jobbnummer
4410517

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