Our site in Zug is looking for a dedicated Staff Engineer Supplier Quality!
Scope of the role:
Determines methods and solutions for complex engineering problems. Applies advanced quality engineering techniques and analyses within a discipline. This level of Engineer is a fully qualified professional, proficient in the utilization of current quality engineering theories and practices. Willingness to travel to supplier, client, or construction site locations, is expected.
KEY RESPONSIBILITIES
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
