Basic Function and Scope of the Position:

The Staff Mfg/Ops Quality Engineer will be responsible for support and leadership of Quality Engineering activities in Life Cycle Engineering, New Product Development, CAPA, and process improvement activities. In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to CFDA, FDA and ISO 13485 standards. You are accountable for driving change, establishing sustainable business processes, improving products, and providing senior management with actionable business and product data. This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the application of quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD). This position will have direct interaction with Manufacturing operations and Lifecycle Management group to lead compliance initiatives. The position may have responsibility of Quality oversight for more than one manufacturing area. The position will be responsible to lead complex investigation for CAPA/ECI/Non-conformance. This position will also prepare, present Quality Metric to management and external regulators as required. As part of the responsibility the candidate will work with cross functional team to establish manufacturing walk through and participate in continuous improvement opportunities.

Tasks and Responsibilities:

• Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations
• Facilitate communications between China customers and the site. Act as the key point person for both outbound and inbound communication between the segment team and China customers.
• Drive activities in prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Assists in detecting trends/recurring issues; and reports on analysis, makes recommendations, and drives programs to improve products and processes
• Collaborates with cross functional team to identify, prioritize and execute business critical quality initiatives
• Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Work with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
• Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
• Provide consultation to end users and process owners with regards to data collection, analysis and creation of validation reports.
• Review verification and validation reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
• Coordinate issue resolution using a risk-based approach
• Identify areas and opportunities to improve quality system processes
• Ensure product development and validation programs meet requirements of FDA and ISO 13485.
• Participate in investigations and ensure CAPA findings, risks, recommendations, Non Conformances reporting and outcomes are appropriate and are clearly documented and communicated
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
• Other such duties that may be determined by Management.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Requirements :

• 7-10 years’ experience in quality assurance field, in a regulated environment;
• Experience in Diagnostic Medical Device industry would be preferred.
• Must be able to speak and write in mandarin.
• Quality Certification preferred (e.g., CQE, CQA, SQE, 6-Sigma, or similar certifications)
• Experience applying quality regulation standards (e.g 21CFR820, ISO 13485, ISO 14971, IVDD, ISPE Baseline guides and ASTM E2500-07 Verification Guideline)
• Practical experience in design control risk management, validation, change control etc.
• Experience with CAPA and failure investigation tools and techniques
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE,

and trend analysis) * Extremely strong communication, facilitation, planning, problem-solving and organizational skills

• Strong influencing and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Operates with high level of independence to investigate and resolve compliance issues, lead projects, plan and implement improvements, and achieve goals

Education:

Bachelor’s degree in Engineering, Science, or other related field required (or equivalent combination of education and experience) and a minimum 7 years of related experiences.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.