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QUALITY ASSURANCE ENGINEER – US —* LIMITED ASSIGNMENT*

Northbrook, Illinois Nanosphere, Inc.

POSITION SUMMARY

The Quality Assurance Engineer participates in the design, creation, implementation and monitoring of programs and methodologies to ensure that assigned Luminex products meet established specifications, design criteria, quality standards and customer requirements. QA Engineer leads internal/external audits and continuous improvement efforts. QA Engineer provides sustaining and design control quality support for on-market products and products under development. QA Engineer develops and provides leadership for Quality System processes. This open position’s focus is quality support of the Luminex instrumentation systems. Familiarity with electromechanical systems is key to success in this position. Specifically, this role focus includes new product protocol/validation support.

ESSENTIAL JOB DUTIES
Key Responsibilities of the Job:

– Evaluates deviations, non-conformances, customer complaints and process/product change control for completeness and impact on quality for on-market products

– Reviews, consults and approves Risk Analysis

– Serves as Quality representative on product development teams responsible for Design Control requirements

– Provides leadership and guidance for developing equipment/product/process Verification & Validation Protocols

– Review records for product release and documents for completeness & accuracy under a production schedule

– Develops and implements quality system documentation

– Identifies key performance metrics and develops reporting mechanism

– Prepares and presents material at meetings

– Identifies, investigates and leads other departments to resolve quality issues

– Leads internal and supplier compliance audits to established Quality System Manual and applicable regulations and standards

– Supports supplier quality activities
– Leads continuous improvement opportunities and works cross-functionally to implement corrective/preventive actions

– Supports Quality system training and participates in the development of training programs regarding all aspects of producing quality products

– Acts as a resource within and cross departmental for quality related questions & challenges

– Acts as Escort during external audits/inspections

JOB REQUIREMENTS
Competencies:

– Learning on the Fly – learns quickly/open to change

– Organizational Agility – knows how to go through the proper channels to get things done

– Peer Relationship – cooperative, team player, trusted and supported by peers

– Planning – sets specific goals and objectives, ability to plan for the length and difficulty of assignments, ability to break down projects into specific tasks/steps

– Priority Setting – focuses on what is most important

– Written Communications – effectively communicates in writing

Required Education/Training:

– Bachelor degree required, in a life science/engineering discipline required

Required Certifications/License/Special Skills:

– Excellent interpersonal, verbal and written communication skills

– Certification in a quality discipline preferred, such as CQM, CQA, CQE, etc.

– Strong computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred

– High degree of problem solving and analytical skills

– Strong organizational and time-management skills Required Work Experience:

– Experience in a Good Manufacturing Practices (GMP) environment required, preferably in medical device industry

– Working knowledge of current industry quality practices under QSRs & ISO-13485

– Experience with conducting internal & supplier audits preferred

– Minimum 5 years’ experience in regulated environment, previous Quality experience required

– Experience with corrective & preventative action is preferred

– Experience with change control is preferred

WORKING CONDITIONS

– Must work onsite at Luminex office at least 90% of the time

– Travel may be required approximately: 10% of the time

– Work is normally performed in a typical manufacturing work environment

– Possible exposure to mechanical, biologic and chemical hazards

– Frequent use of personal computer, copiers, printers, and telephones

– Frequent standing, walking, sitting, listening, and talking

– Frequent work under stress, as a team member, and in direct contact with others

PHYSICAL REQUIREMENTS:

– Lifting/Use of Strength is Medium (20 to 50 pounds)

– Climbing on the job is required: Occasionally–Up to 33% of the time

– Kneeling on the job is required: Occasionally–Up to 33% of the time

– Reaching on the job is required: Occasionally–Up to 33% of the time

– Stooping on the job is required: Occasionally–Up to 33% of the time

– Vision (Color) on the job is required: Occasionally–Up to 33% of the time

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