CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.

CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Full Service Engineering consulting services headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.

Provides quality oversight for design control lifecycle activities for the auto injector platforms.  Provides input/review for combination product related design projects, quality system records and design control procedural deliverable requirements.  Guides design verification and validation plans.  Assesses and improves systems, procedures and practices.  Approves protocols and reports as needed.  Responsible for oversight of Design Control Lifecycle.  Provides Quality oversight for R&D, human factors and design verification  

ROLE RESPONSIBILITIES

• Provide oversight to the Product Technology team, R&D (Columbia, MD) and STL manufacturing site to ensure compliance with FDA’s regulations / guidance documents as well as site SOPs
• Review/Approve impact assessments for complex/significant CAPA and Change Management records and develop execution plans
• Facilitate risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed
• Review and Approve Design History and Risk File documentation
• Utilize Design History and Risk File documents to assess risk resulting from complex/significant changes, manufacturing events and customer complaints
• nation Product technical assessments
• Represent the Quality Unit during Design Reviews
• Provide Design Control lifecycle, procedure and policy training as necessary.
• Identify and correct deficiencies in procedures and practices
• Represent the Quality Unit during regulatory inspections and audits

• Bachelor’s Degree in Engineering or Science
• 7-10 years’ experience in medical device or combination product manufacturing within the Quality function
• At minimum 5 years providing direct oversight to the design control lifecycle, human factors studies and DHF
• Well versed in ISO13485 and 21CFR820 requirements
• Critical thinking ability and attention to detail
• Effective technical writing ability and verbal communication skills
• Computer skills including MS Office and MiniTab
• Demonstrated applied knowledge of Failure Modes Effect Analysis (FMEA), CAPA, Root Cause Analysis and statistical methods as applied to Quality.

PREFERRED QUALIFICATIONS

• Certified Quality Engineer, Quality Manager or Six Sigma Black Belt
• Experience with DHF remediation

• All information will be kept confidential according to EEO guidelines.
• Please attach WORD resume in your profile
• Must be local to the client or willing to temp relocate there 
• Work is on-site
• This is a contract assignment NOT a full-time job
• 1099 OR W2