Program Manager / Field Actions
52 Discovery Irvine, CA 92618 US
Job Description
Program Manager / Field Actions
Job Overview:
We are seeking a highly organized and proactive Program Manager to lead and oversee field actions within our organization. In this pivotal role, you will ensure the seamless execution of field corrective and preventive actions, supporting our commitment to quality and regulatory compliance. The successful candidate will manage all related activities, from initiation to closure, ensuring documentation and communication meet regulatory standards and internal quality management system requirements.
Key Responsibilities:
- Lead and coordinate field actions, including recalls, corrections, customer notifications, and removals, ensuring they are executed promptly and in accordance with applicable regulations and company standards.
- Collaborate closely with the Quality team, global sites, and customers to ensure compliance with established protocols, accurate product accounting, and effective reconciliation of field actions.
- Develop, review, and manage communication materials such as customer notifications, marketing flash documents, and status reports related to field actions.
- Monitor and document all activities associated with field actions, maintaining comprehensive records from initiation through closure, in compliance with regulatory and quality standards.
- Act as a key point of contact, effectively communicating with internal teams, field personnel, and customers to facilitate clear understanding and timely resolution of issues.
- Support continuous improvement initiatives related to quality compliance and field action processes.
- Perform additional duties as required to uphold regulatory and quality standards.
Qualifications & Experience:
- Proven experience (minimum of 3-5 years) in a similar role within the medical device or regulated industry, with a strong understanding of quality systems and regulatory requirements.
- Excellent organizational skills and a demonstrated ability to maintain meticulous records.
- Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint, with the ability to generate reports and manage spreadsheets efficiently.
- Strong written and verbal communication skills, capable of engaging effectively with diverse stakeholders at all organizational levels and across international sites.
- Ability to work independently with minimal supervision and manage multiple priorities effectively.
Preferred Qualifications:
- Experience working specifically within the medical device industry, especially in roles related to quality assurance, regulatory compliance, or field actions.
Education:
- Bachelor's degree or equivalent experience in a related field.
Why Join Us?
This role offers an exciting opportunity to play a key part in maintaining the highest standards of product safety and quality. You'll work within a dynamic team dedicated to continuous improvement and customer satisfaction, with opportunities for professional growth and development in a rapidly evolving industry.
Meet Your Recruiter
Nina McCann
On-Site Manager
A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.
Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.