Engineer I, Quality

Job Summary:

The Quality Engineer is responsible for defining and addressing Quality Improvement opportunities in all GMP areas. Has extensive knowledge of cGMPs and quality processes and procedures and accountable for the Annual Product Quality Review (APQR) and investigations for non-conforming products and materials.

Primary Duties & Responsibilities:

• Critically review various types of documentation to ensure completeness, accuracy, and compliance including deviation and OOS investigations, CAPAs and change controls
• Generates Annual Product Reports
• Monitor and communicate daily, weekly and monthly quality performance results, productivity results and inspection backlog data. Monitor and report on vendor Quality performance.
• Evaluate new vendors. Provide vendors with Shiseido Quality requirements, expectations, standards and procedures. Conduct business review meetings with vendors on-site and at their facility to discuss quality related issues and improvements. Perform Vendor audits.
• Conduct training of QC Incoming and Production personnel on an as-needed bases. Maintain conformance to established Specifications, Test Methods, Quality Standards; GMP, FDA and OSHA compliance. Write Work Instructions and ensure that they are followed.
• Other duties as assigned.

Working Relationships/Key Stakeholders:

• Solid and Cooperative working relationships with Suppliers, Production, Planning, NPD, Customer Service, Purchasing, Accounting, Warehousing, IT and Human Resources departments.

Qualifications & Competencies:

• Minimum of 3 years of QA/QC experience in pharmaceutical, personal care or cosmetic industries
• Strong working knowledge of attribute and variable inspections, packaging conformance testing, ANSI/ASQZ1.4 or ISO 2859 sampling methodology, schematic interpretation, cGMP experience in Supplier/Contract Manufacturer or Internal Auditing processes
• Positive leadership and team building skills
• Technical Skills - Strong mathematical, technical and problem-solving skills; decision making, data collection and analysis
• Ability to multi-task and work independently
• Strong communications and interpersonal skills - Strong verbal and written communication (English)
• Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook. SAP or other production system environment experience a plus.

Trust 8 Competencies

Below is a list of Trust 8 Competencies designed to help employees at Shiseido Americas succeed as the company continues to evolve and innovate.

1. Think Big: Adapt a big-picture perspective. Deliver new values through creativity.
2. Take Risks: Embrace Risk, Practice “Trial and Error and Trial”.
3. Hands On: Consider Front-line realities when making decisions. Take the lead from end to end.

4. Collaborate: Leverage the diverse capabilities of colleagues.
5. Be Open: Create an environment that encourages everyone to speak up.
6. Act with Integrity: Be sincere and humble at all times.
7. Be Accountable: Commit to the goal. Take accountability for the execution.
8. Applaud Success: Create a culture that celebrates success.

Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law