Job description

Summary

We are a manufacturer of thermoformed plastic components serving medical, pharma and food products companies. We welcome dedicated, hard-working individuals to join our team. Our long-term employees take pride in performing their duties with speed and accuracy. Our goal is to provide a safe, “happy and harmonious” workplace for our current and future coworkers. We offer in-house training and promotion to the right personnel

The Quality Systems and Regulatory Affairs Specialist coordinates and documents internal regulatory processes, such as internal audits, inspections, validation activities, and Management Review. The Regulatory Affairs QMS Specialist also communicates at the highest level with our customers and other regulatory professionals and consults with our team to assure our service to the customers always complies.

Responsibilities

· Create required documents for ISO 13485, ISO 14001, CA Green Business.

· Ensure that the company's Quality System is compliant with the relevant current regulations.

· Manage Document Control system.

· Manage coordination of regular Management Reviews.

· Support auditing workflows internal and external.

· Participate in audits by internal and external audit authorities.

· Track Non-Conformances and status of corrective actions.

· Maintain company compliance profiles in 3rd party applications like Ecovadis and Sphera BOMcheck.

· Maintain records and documents that support regulatory requirements and activities.

· Regulatory Affairs Subject Matter Expert (SME).

· Remain current on Global Regulations and Standards; provide RA leadership

· Advise upper management on current and emerging regulatory requirements and how to satisfy those requirements.

· Further responsibilities include support of the Engineering and Quality teams, providing guidance and serving as a resource for CAPA, internal audit and vendor/supplier audit programs, process validation.

Qualifications

· 1-3 years in an ISO and FDA regulated environment (GMP, MDR, QSR, ISO 13485, ISO 9001, ISO 14001)

· 3+ years of professional Quality experience

· Regulatory Affairs Certification (RAC) by the Regulatory Affairs Certification Board (RACB) desired

· Bachelor of Science Degree in Quality, Plastics, Industrial, Mechanical, Chemical Engineering or equivalent

Job Type: Full-time

Salary: $83,200.00 - $114,400.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8-hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Burlingame, CA 94010: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: One location

Job Type: Full-time

Pay: $83,200.00 - $114,400.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Burlingame, CA 94010: Reliably commute or planning to relocate before starting work (Required)

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: In person

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