Position Summary:
This role is responsible to ensure that design transfer and manufacturing operations activities are executed in compliance with Illumina’s established Quality Management System (QMS) and relevant international/national regulations. These activities include, but are not limited to, validation, non-conformance, customer complaints, risk assessment and support maintenance of the QMS.
Position Responsibilities:
- Serve as Quality representative on project teams for new product transfers
- Review and approve manufacturing operational activities, such as Device History Records (DHR), nonconformance, CAPA, RMA, and customer complaints
- Work with cross-functional teams to resolve operational quality issues
- Trend, analyze and monitor key performance indicators, suggest improvements and escalate to supervisor/management as necessary
- Ensure the quality systems meet customer, corporate, or internal requirements and any other related requirement within the Quality Management System
- Participate in management of corrective action program (customer complaints) to ensure timely follow-up, completion and documentation of corrective actions
- Manage customer complaints and work closely with cross function in issue investigation and ensure timely response of to corporate/ customer
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits
- Other such duties that may be determined by Supervisor
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.
Position Requirements:
- Bachelor’s degree in Engineering or Biological/Life Sciences or equivalent field
- Minimum 5 years of experience in a medical device manufacturing environment.
- Excellent interpersonal, verbal and written communication skills
- Ability to apply experience to meet 21 CFR 820 and ISO 13485 requirements
- Strong analytical, problem-solving and decision-making skills; Certified Quality Engineer, or equivalent, is a plus
- Experience in failure investigation, technical report writing, data mining, trend analysis and statistical analysis
- Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools
- Proficient in computer systems such as Microsoft Office & SAP
- Experience with statistical analysis packages, e.g. JMP, Minitab is highly preferred