Product Surveillance Engineer Lead

Essential Responsibilities:

• Facilitating complaint investigation

• Engaging product design owners to determine effective CAPA

• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)

• Reviewing appropriate criteria for closure of complaints

• Owning and communicating metrics on status and driving achievement of goals

• Complete all planned Quality & Compliance training within the defined deadlines

• Identify and report any quality or compliance concerns and take immediate corrective action as required

• Identify and report any compliance gaps related to applicable regulations and standards

• Ensure zero repeat findings from previous internal and external audits within area of responsibility

• Process and report complaints, metrics, and data in a timely and compliant manner

• Provide objective evidence of complaint handling process through compliant documentation.

Qualifications/Requirements:

• Bachelor’s degree in engineering or health sciences field; or a High School diploma/GED and minimum 5 years work experience in a Quality or Regulatory Assurance related field

• 3 years’ experience in medical device or pharmaceutical industry in Quality or Regulatory related role

• Experience working with pharmaceutical/biologic products

• Ability to quickly assess situations and make decisions

• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment

• Ability to work independently and in a team setting

• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).

• Excellent interpersonal, organizational, and influencing skills

If you are interested please contact:

Ujjwal Mane

973-805-7557

ujjwal.mane(at)collabera.com