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 oversight and guidance for risk management file lifecycle activities for the auto injector platforms.  Provides input and risk review for combination product related design projects, quality system records and design control procedural deliverable requirements.  Leads and facilitates risk assessment activities and guides design verification and validation plans.  Responsible for risk management systems, procedures and practices.  Approves protocols and reports as needed.  Responsible for oversight of Risk Management File portion of the DHF.

• Bachelor’s Degree in Engineering or Science
• 7-10 Years’ Experience in with practical application of risk management concepts within FDA regulated industry
• Well versed in ISO risk management standards
• 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 or Six Sigma Black Belt
• Experience with DHF remediation

REQUIREMENTS

• Bachelor’s Degree in Engineering or Science
• 7-10 Years’ experience in with practical application of risk management concepts within FDA regulated industry
• Effective technical writing ability and verbal communication skills
• Demonstrated applied knowledge of Failure Modes Effect Analysis (FMEA), CAPA, Root Cause Analysis and statistical methods as applied to Quality.

PREFERRED: 

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

1. All your information will be kept confidential according to EEO guidelines.
2. Please attach WORD resume in your profile
3. This is a 6-12 m consulting opportunity with CP Professional Services on-site at our client in St. Louis, MO
4. NO 3rd party agencies please - do not send your candidate resumes.