ASP (Advanced Sterilization Products) is a leading designer and developer of innovative instrument sterilization, high-level disinfection, and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj. Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with J&J/ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans. Advanced Sterilization Products is currently recruiting for a Team Lead, Supplier Quality Engineer in Zug, Switzerland.
Responsibilities
Lead and/or Supports Supplier Quality Management group based in Switzerland
Support Supplier Quality Globally
Coaching others in supplier quality or other teams.
Participates internally with ASP R&D Engineering, Operations Engineering and Manufacturing to identify potential areas of process variability, address root causes and implement improvement under general supervision
Lead new and existing supplier assessments to determine the state of Quality Systems, GMPs and Process Capabilities in support of ongoing business and new product introductions
Ensure that supplier systems are aligned with current regulatory requirements, standards, industry trends, and J&J policies and standards
Escalate issues and leading risk assessments and risks mitigations as appropriate
Collaborate with key business partners and drives non-conformance investigations to ensure timely and robust corrective actions
Communicate product and compliance risk, write, review and execute documents and procedures and participate in investigations or for-cause supplier site-audits
Monitor, trend, identify issues, and drive the resolution of supplier quality issues as well as execute and lead negotiations of External Manufacturer Quality Agreements
Act as the process quality subject matter expert on cross-functional project teams, as well as development and analysis of monthly and quarterly metrics
Lead supplier change control documentation
Other responsibilities may be assigned and not all of those listed above may be assigned
Qualifications
A minimum of a Bachelor's degree in a technical discipline (Math, Science, Engineering or Information Technology) is required; a degree in Engineering is preferred
A minimum of 3-5 years work experience is required. Experience working in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
Direct experience in plant and/or supplier GMP auditing is preferred
Prior manufacturing, plant or technical background is required
Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required
Experience with documentation and technical writing skills, in a regulated compliance environment, is required
Quality Auditor or Lead Auditor certification is preferred
Prior experience with FDA inspections is desirable
Experience with Six Sigma Process Excellence tools, training and/or certification is desirable
Broad knowledge of Quality System Regulations and Supplier Quality Management principles is desired
Demonstrated ability to translate GMP requirements into SOPs and specifications
Understanding of GMPs as they pertain to manufacturing, testing and packaging of drug products
Demonstrated ability to identify compliance risks and assess business impact, are required
Ability to manage complexity and lead a diverse team is essential
Deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
Strong analytical skills, metrics development and ability to identify trends are desirable
This position may require up to 40% travel domestically and internationally
