Primary Function
The Design Control Coach reviews, maintains and educates the department to the quality system procedures surrounding the development of medical devices and works within an interdisciplinary team of engineers, quality and regulatory professionals to establish procedures that are compliant, effective and efficient.
Essential Job Functions/Duties
• Review, revise and/or create Quality System Regulations (QSR) procedures and instructions related to Design Control (DC) regulations
• Verify regulatory compliance of project Design History Files (DHF audits)
• Run short term, long-term, and/or design control focused projects consistent with corporate and departmental objectives by engaging the efforts of other engineers, manufacturing, regulatory, QA and marketing
• Resolve internal DC related CAPA issues and complete any associated long term actions
• Review, revision and/or creation of QSR procedures and instructions related to compliance with ISO13485 and global guidelines pertaining to Design Controls compliance for medical devices.
• Establishing training requirements and deliver presentations associated with FDA cGMP (21CFR820), ISO 13485, 14971, IEC 62366-1 or other Medical Device related standards and guidances.
• Maintain systems storing and tracing Design Control related data.
• Provide support and/or participation in regulatory and ISO audits.
• Serve as a mentor, trainer, and resource to the department for aspects critical to performing job functions
• Design training programs and measurable metrics to support approved solutions within the company.
• Assist Design Control Planning/Coaching efforts on ongoing projects.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must maintain company quality and quantity standards
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must have effective oral and written communication skills
Minimum Work Experience/Educational Requirements
• BS in Engineering or Engineering Technology; or experience of such kind and amount as to provide a comparable background
• Experience using analytic skills and problem solving
• Experience with CFR 820.30, ISO 13485, ISO 14971
• Experience writing, implementing and training Quality System Procedures (preferred)
• Minimum of 10 years industry experience is required for this position.
Physical Requirements/Work Environment
• Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works partially under general office environmental conditions
• Moderate exposure to noise level in the work environment that is moderate to occasionally loud
• Occasionally lifts and/or moves up to 50 pounds
• Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; talk and hear