Quality Engineer II, Complaints
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right Job Summary The primary purpose of this job is to execute and support the Complaint Handling and regulatory reporting processes under the direction of the Quality Systems Engineer. This position will also be responsible for participating in development of processes that comply with published regulatory requirements. This position will also conduct detailed quality analysis and trending of data. Key Accountabilities and Responsibilities 1. Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to:
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. 2. Responsible for supporting and performing customer complaint investigations by working in collaboration with Operations, Quality and R&D associates to facilitate the completion of complaint investigations in a timely manner and determining need to escalate issues. 3. Reviews test procedures and plans related to complaint investigations prior to executions, conducts failure analysis and inspection on products, processes and materials 4. Responsible for completion of Medical Device Reports (MDRs) and Medical Vigilance Reports (MDVs) determination checklists. 5. Responsible for completion of applicable forms for submission of reportable complaints to applicable agencies. 6. Responsibly for metrics coordination and reporting to manager. 7. Provides Quality Systems and Compliance consulting to Operations associates related to Complaint Investigations, and other compliance topics. 8. Independently performs assignments, receiving instruction only regarding general expected results. 9. Assists with quality assurance functions in support of needs directed by Quality Management. 10. Performs other functions as required. Job Requirements Minimum Education:
Bachelor's degree in a related field or equivalent amount of work experience Minimum
Experience:
Bachelor's degree with 3-5 years of experience in Quality Assurance and Compliance or 6-10 years of experience within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or regulated industry. Specialized Knowledge:
Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills. Special Skills:
Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired. U.S. Applicants:
EOE/AA Disability/Veteran.
Salary Range:
$100K -- $150K
Minimum Qualification
Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. 2. Responsible for supporting and performing customer complaint investigations by working in collaboration with Operations, Quality and R&D associates to facilitate the completion of complaint investigations in a timely manner and determining need to escalate issues. 3. Reviews test procedures and plans related to complaint investigations prior to executions, conducts failure analysis and inspection on products, processes and materials 4. Responsible for completion of Medical Device Reports (MDRs) and Medical Vigilance Reports (MDVs) determination checklists. 5. Responsible for completion of applicable forms for submission of reportable complaints to applicable agencies. 6. Responsibly for metrics coordination and reporting to manager. 7. Provides Quality Systems and Compliance consulting to Operations associates related to Complaint Investigations, and other compliance topics. 8. Independently performs assignments, receiving instruction only regarding general expected results. 9. Assists with quality assurance functions in support of needs directed by Quality Management. 10. Performs other functions as required. Job Requirements Minimum Education:
Bachelor's degree in a related field or equivalent amount of work experience Minimum
Experience:
Bachelor's degree with 3-5 years of experience in Quality Assurance and Compliance or 6-10 years of experience within Quality Assurance and Compliance in the Medical Device, Pharmaceutical, or regulated industry. Specialized Knowledge:
Strong understanding of applicable regulations and standards (21 CFR 803, 806, and 820, and ISO 13485). Problem Solving and training skills. Special Skills:
Proficient in Microsoft Office applications required. Familiarity with eQMS Programs (TrackWise, EtQ, etc.) desired. U.S. Applicants:
EOE/AA Disability/Veteran.
Salary Range:
$100K -- $150K
Minimum Qualification
Systems Architecture & Engineering, Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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