Amick Brown is seeking an experienced Product Complaint Associate
for our direct client.
Location: Santa Clara, CA 94086.
Duration: 1 year with possible Extension
Primary Function of Position:
The Post Market Surveillance Systems Analyst will provide support to the client’s Post Market Surveillance Team. Primary responsibilities include, but are not limited to, working closely with the Post Market Surveillance leadership team to ensure system support and needs are met.
Roles and Responsibilities:
- Support systems and processes that Post Market Surveillance requires to manage complaints, regulatory reporting and other related processes
- Works with teams that impact or feed into the Post Market Surveillance process to ensure that processes are aligned and teams are aware of effects of work flows.
- Drives process improvements and automation.
- Works with Post Market leadership to streamline work flows and provide feedback.
- Works closely with IT to manage issues, improvements, system enhancement releases, and automations. System enhancement releases including requirement gathering, test scripts authoring, validation document review, test script execution, regular status updates to upper management. Alignment with cross functional teams.
- New or updated Regulation requirement implementation and support.
- Assist in continuous process improvements to ensure timely complaint investigations with the highest level of quality occur.
- Identify gaps in the complaint process and support implementation of corrective plans and other solutions to ensure continued compliance with applicable regulations
- Participate as the Post Market Surveillance representative on other projects as needed or requested.
- Minimum requirements in order to adequately perform the responsibilities of this position
- Education: B.S. or higher in Biomedical Engineering, Electrical Engineering or Mechanical Engineering preferred
- Non-technical degree with equivalent complex medical device experience acceptable
- Experience/Skills: Minimum 5+ years relevant Compliance experience working in a medical device company, regulated environment or equivalent
- Quality or regulatory affairs experience in a medical device company or comparable experience:
- Experience in U.S. FDA Complaint / Compliance requirements and Medical Device Reporting
- Experience in the European Medical Device Directive and vigilance reporting requirements
- IT implementation or management from a business perspective experience
- Ability to independently analyze various forms of quality data provide actionable output
- Ability to synthesize data and observations to see trends, identify gaps against regulations and make logical recommendations for action
- Independent thinker, willing to present alternative conclusions or inferences
- Ability to influence others cross organizationally at various levels regarding Post Market Surveillance requirements
- Experience in continuous improvement methodologies
- Strong computer skills, particularly with Excel and the ability to learn new applications, Microsoft Office Suite
- Strong verbal and written communication skills, proven ability to translate analytical information into effective presentations
- Good interpersonal skills and able to work well with cross-functional teams
- Good project management skills
- Solid attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting
- Must be self-directed with the ability to work with minimal supervision
- Excellent attention to detail, organization skills and extensive ability to multi-task and project manage across multiple projects/activities in a team setting
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs