- Certified Lead Auditor with extensive auditing experience
- Lead Auditor for supplier audits at both sites (Mahwah & Fairfield) including pre and post audit related documentation and compliance.
- Manage the Supplier Audit Program for both sites.
- Ensure compliance to Getinge procedures.
- Execute and follow through from intiation to completion on findings from supplier audits.
- Manage supplier quality performance and measurement KPIs and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
- Lead quality issues with suppliers and partner with internal customers. Lead effective supplier containment and corrections/corrective actions.
- Lead efforts on improvement of quality of suppliers.
- Drive supplier requirements and supplier performance objectives
- Supplier Development; establish & sustain effective partnerships with suppliers, develop technical capability across both Mahwah & Fairfield sites
- SME in Supplier Quality for external audits as needed. Ensure regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies. This is applicable towards both Mahwah & Fairfield sites.
- Experience in Corrective Action Preventive Action.
- Ensure compliance to Supplier Audit Schedule for both Mahwah & Fairfield sites
- Lead/provide support to other SQEs in the team for both Mahwah & Fairfield sites
- Lead multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion for both Mahwah & Fairfield sites.
- Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance for both Mahwah & Fairfield sites
- Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system for both Mahwah & Fairfield sites
- Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers
- Ensure alignment/lead standardization efforts on supplier management processes across sites.
- Engages interest and participation of others and has a collaborative approach to working with others
- Proactively contributes to the team
Required Knowledge, Skills and Abilities:
- Knowledge of the principles and practices of process validation.
- A working knowledge of quality improvement tools and techniques.
- Knowledge of auditing procedures.
- Work related travel (Domestic and overseas) 10 – 25 %
- Strong knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA)
- Lean Manufacturing knowledge
- Knowledge of ISO13485/ISO45001/OHSAS18001
- Understanding of ISO14001
- Knowledge of measurement techniques, Metrology, Inspection Methods and Equipment
- Understanding and interpretation of engineering drawings
- Understanding manufacturing processes
- Ability to work in a diverse and dynamic environment.
- Good communication and interpersonal skills, Listening skills, Negotiation skills
- Ability to present data effectively
- Problem-solving skills
- Understanding of Health and Safety practices
- Team working skills
- Analytical skills
- Understanding of cost and financial impacts
- 5+ years' experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment.
- Supplier Auditing Experience.
- Minimum 5 years Supplier Quality Engineering experience.
- Certified Lead Auditor
- Upto 70% Travel
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