Engineer II, Regional Quality

Job Summary:

The Quality Engineer is responsible for performing Risk Assessment and Risk mitigation for new product launches in the areas of component manufactures and contract manufactures. 

This position will require to ensure quality assurance for all new launches during line trial. The scope is to cover complete end to end production risk assessment and mitigation on components, bulk and fill and assembly. In addition, work with packaging/R&I/NPD members to review quality issues during line trials.

Primary Duties & Responsibilities:

• Become familiar with risk assessment process for Contract manufactures.
• Conduct Risk assessment for new launches with CM and component suppliers
• Attend line trials for Level 3 & 4 launches at the CM as needed
• Ensure Line trial report is fill out by the CM and approved by Quality/Packaging and R&I.
• Provide support in trouble shooting of formula and process related issues as needed
• Provide Gate 2.5 training to CM.
• Maintain current list for all level 3&4 launches
• Work closely with the Packaging/R&I/NPD.
• Critically review Risk assessment provided by suppliers and provide feedback.
• Ensure all corrective actions are done by supplier before Gate 2.5
• Other duties as assigned

Working Relationships/Key Stakeholders:

• Solid and cooperative working relationships quality, packaging, product development and innovation center departments.
• Actively participate in the launch management process.

Financial Accountability

• Travel budget

Qualifications & Competencies:

• Bachelor’s Degree in a scientific or engineering field and 2-3 years of experience in Quality department (Cosmetics industry preferred)
• Solid knowledge of cGMP systems as applied to ISO 22716 and OTC Cosmetics and drug products.
• Solid knowledge of bulk and filling processes for cosmetic products
• Solid knowledge in quality validation for processing and filling operations 
• Auditing experience, in the areas of component manufacturing, bulk processing and fill and assembly
• Understanding of foreign regulations, guidelines and practices for cosmetics and OTC products.
• Leadership Skill - Strong drive to deliver business goals and identifies new opportunities.
• Language Skills- Ability to read, analyze, and interpret general business technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Reasoning Ability- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Computer Skills - Strong knowledge of Microsoft Office is required

Competencies