Job description

DESIGN CONTROL CONSULTANT (3-month)

SUMMARY:
Design Control Consultant needed to support compliance initiative for a growing medical device organization

DUTIES & RESPONSIBILITIES:
* Review existing Design Control policies, SOPs and related documentation
* Provide SME input, feedback, guidance, recommendations, re-writes, edits, etc. specific to the usability and compliance requirements of the organization
* Participation in team meetings
* Other duties, as required

QUALIFICATIONS & REQUIREMENTS:
* Medical Device Quality Systems and Design Control expertise for companies that are not large, and do not have multiple products on the market
* Pragmatism and excellent written, verbal and interpersonal communication skills. Writing skills must include experience analyzing, writing and editing Design Control policy/SOPs and related documentation
* Proven knowledge of relevant FDA compliance and related international guidance and requirements
* Relevant degree

LOCATION:
Work can be performed remotely from home

Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• medical device quality system: 5 years (Preferred)
• design control: 5 years (Preferred)
• reviewing design control policies, SOPS, etc.: 5 years (Preferred)
• analyzing, writing, editing design control policy/SOPs: 5 years (Preferred)
• FDA and international compliance knowledge: 5 years (Preferred)

Work Location: Remote

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