Quality Specialist

2 weeks ago

Fort Worth, United States ML OUTSOURCING SERVICES PRIVATE LIMITED Full time

Job Title: Business Process Analyst II

Duration: 9 Months

Location: Fort Worth, TX


Job Description:


• Author Risk Management documentation for Class II & III Medical devices in compliance with ISO 14971 & EUMDR

• Lead the development of Design History Files for class II & III Medical Devices in compliance with ISO 13485, EUMDR, MDSAP, and other standards/regulations relevant to medical Device Design & Development

• Author Critical Design History File Documents, and lead cross-functional discussions to ensure alignment through the entire Design & Development Team

• Serve as the representative for Design Control Team at cross-functional core team meetings

• Lead design reviews, assign and review action items or delegate these tasks.

Job Purpose (I took most of this from the career ladder webpage):

• Works with wide latitude for unreviewed action or decision and represents the corporate direction in science and technology. Key functional expert who manages, direct and coordinates the activities of a specific area.

• Strategic and/or management interface.

• Supports engineering or scientific decision making by providing advice and recommendations to global project teams. Develop concepts and propose approach, to address identified ophthalmic medical device/science/technology needs.

• Originate and apply complex concepts and propose new and unique approaches, methods, procedures and designs with regular use of creativity and originality to research and/or development.

Ideal Background (I took most of this from the career ladder webpage):

• At a Minimum: Bachelor’s + 7 years relevant experience, MS + 4 years relevant experience, PhD + 3 years relevant experience

• Project management expertise with proven results in multiple areas.

• Possess significant leadership skills to effect change.

• Has proven ability to develop/implement advanced processes, techniques related to product development and/or critical systems.

• Proven leadership track record of results.

• Capability to motivate complex teams cross-functionally; directs strategic and business goals.

• Expert knowledge of ISO, FDA, MDD and regulations applicable to the design and development of medical device/science/technology.

• Provides expert input to develop solutions to complex problems that require the regular use of creativity, and originality.

• Robust process management, problem solving skills and superior presentation capabilities.

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