Compliance Analyst Jr
Our client is currently seeking a Compliance Analyst -Jr (Medical Device).
This is a 12
month contract opportunity and will require basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
Please submit all qualified resumes to dglodek@judge.
com.
The Compliance Analyst- jr will have the following
Responsibilities:
Manages and supports supplier quality projects.
Performs research to understand requirements of pertinent federal, state and local regulatory schemes.
Monitors operational compliance practices and performs risk assessments.
Analyzes existing policies, identifies gaps and recommends new or revised policies and procedures, approval processes, and monitoring methods.
Provides technical expertise in identifying and reducing areas of potential risk.
Gathers data, conducts analyses, and prepares work related to compliance reviews.
Participates in developing new compliance systems and tools to support large compliance projects.
Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.
e.
FDA, IMB, Notified bodies, etc) Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with suppliers.
Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions Support continuous improvement activities focusing on supplier quality Support the assessment of supplier changes Participate in supplier reviews for assigned suppliers as required Participate in cross functional projects Support the developments and approval quality assurance agreements with suppliers Professional Requirements- Willing to travel in support of business needs to different geographical locations Good knowledge of continuous improvement methodologies Qualifications & Requirements:
Required skills include the ability to partner with business personnel at various levels of the organization, strong verbal and written communication, analytical and project management skills.
Associate or Bachelor's Degree in Engineering/Science/ Arts or Food industry 0 to 2 years of experience in manufacturing environment or equivalent Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable Preferred industries are medical device, aviation, aerospace, automotive and defense Must enjoy working in team environment Must demonstrate good collaboration and communication skills Highly motivated and able to build relationships internally and externally Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction ID:
582965 Type:
Contract Salary:
Open.
Estimated Salary: $20 to $28 per hour based on qualifications.
This is a 12
month contract opportunity and will require basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
Please submit all qualified resumes to dglodek@judge.
com.
The Compliance Analyst- jr will have the following
Responsibilities:
Manages and supports supplier quality projects.
Performs research to understand requirements of pertinent federal, state and local regulatory schemes.
Monitors operational compliance practices and performs risk assessments.
Analyzes existing policies, identifies gaps and recommends new or revised policies and procedures, approval processes, and monitoring methods.
Provides technical expertise in identifying and reducing areas of potential risk.
Gathers data, conducts analyses, and prepares work related to compliance reviews.
Participates in developing new compliance systems and tools to support large compliance projects.
Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.
e.
FDA, IMB, Notified bodies, etc) Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with suppliers.
Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions Support continuous improvement activities focusing on supplier quality Support the assessment of supplier changes Participate in supplier reviews for assigned suppliers as required Participate in cross functional projects Support the developments and approval quality assurance agreements with suppliers Professional Requirements- Willing to travel in support of business needs to different geographical locations Good knowledge of continuous improvement methodologies Qualifications & Requirements:
Required skills include the ability to partner with business personnel at various levels of the organization, strong verbal and written communication, analytical and project management skills.
Associate or Bachelor's Degree in Engineering/Science/ Arts or Food industry 0 to 2 years of experience in manufacturing environment or equivalent Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable Preferred industries are medical device, aviation, aerospace, automotive and defense Must enjoy working in team environment Must demonstrate good collaboration and communication skills Highly motivated and able to build relationships internally and externally Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction ID:
582965 Type:
Contract Salary:
Open.
Estimated Salary: $20 to $28 per hour based on qualifications.
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