Full Job Description
Job Overview
Provide Quality Leadership focusing on Critical Supplier Quality issues and Quality improvement initiatives within Supplier Quality.
Job Responsibilities and Essential Duties
• Provide oversight and direction for Critical Suppliers, Supplier Audits and Supplier Validations
• Ensure primary suppliers have adequate control plans, schedules, and resources to make continued improvements to incoming quality of supplied products
• Identify and perform Supplier process evaluations to identify areas for improvement.
• Recommend solutions to identified problems; suggest methods for improving product quality, design, or manufacturing processes.
• Lead and provide cross-functional support to other quality teams by providing quality expertise.
• Drive the strategic planning, development and implementation of programs designed to improve supplier performance/ productivity and reduce overall costs
• Own Supplier audits to evaluate supplier capabilities, quality systems, processes
• Partner with the PMO group to create timelines, create progress reports, and support all program elements including proactive communications regarding initiatives.
• Influence cross-functional teams to strengthen quality culture.Perform validations and qualification of suppliers to qualify manufacturing process and overall quality of part/component manufacturing.
• Provide leadership in resolving internal and external quality issues related to purchased components including participating in MRB process and assisting incoming quality. Identifies non-conformance trends and leads technical/ root cause investigations and corrective action programs to resolve recurring quality problems.
• Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.
• Executes and assists in special projects as needed.
• Support maintenance of key quality metrics.
• Contributes to the team effort by accomplishing related tasks as necessary.
• Perform other duties as assigned.
Minimum Requirements
• Bachelor's degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience (Master's preferred)
• 7-10 years' experience in the FDA regulated environment.
• Experience in Quality in an FDA regulated industry.
Required Knowledge, Skills and Abilities
• High level of attention to detail and accuracy.
• Leadership and mentoring skills.
• Effective verbal and excellent technical writing skills.
• Ability to communicate and work effectively at multiple levels within the organization.
• Excels at generating and maintaining organized and accurate records.
• Able to work effectively in a high-stress, high-energy environment.
• Able to make effective decisions quickly based on vague or imperfect information.
• Ability to create and maintain professional relationships within all levels of the organization (peers, work groups, customers, supervisors).
• Ability to work independently and as a member of a team.
• Flexibility to operate and self-driven to excel in a fast-paced environment.
• Capable of multi-tasking, highly organized, with excellent time management skills.
Supervision/Management Of Others:
• Provide leadership, direction, and mentoring to Supplier Quality Engineers and supplier-facing quality professionals.
Internal and External Contacts/Relationships
• Work at the Merrimack location while collaborating with all other Getinge's sites. Work location is flexible; remote and office.
• This role will be supplier facing and require relationship building with all critical suppliers.
Environmental/Safety/Physical Work Conditions
• Ensures environmental consciousness and safe practices are exhibited in decisions.
• While performing the duties of this job, physical requirements such as lifting may be needed.
• May work extended hours during peak business cycles
• Some travel required
• Employee must be comfortable working in a Clean Room Environment
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