Quality Engineer- Medical Device Manufacturing- Salary to $80K
Compliance & CAPA Manufacturing Quality Engineer
Salary to $80K DOE
DESCRIPTION:
This position is the process owner for the medical device complaint and CAPA systems at the manufacturing plant. This position receives, documents, maintains and reviews files on complaints reported on customers' marketed products in accordance with company policies and FDA regulations. This position champions the CAPA program by working with key players to ensure appropriate CAPAs are opened and addressed accurately in required timelines. Provides leadership in all areas of medical device complaint handling and CAPA management to ensure that tasks required are performed in an accurate and timely manner.
ESSENTIAL DUTIES AND
Responsibilities:
Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the final closure of the file.
Evaluates complaints for determining MDR events and documents rationale for not filing MDRs as applicable. Escalates complaints appropriately if the complaint is deemed reportable.
Assign or complete, review and approve investigations performed for complaints. Escalates complaint investigations to the CAPA program if required by company procedures.
Follow-up with customers and manufacturing and regulatory personnel to obtain additional information when necessary.
Perform final review for closure of complaint files to ensure accuracy, completeness and attention to detail.
Generate weekly and monthly complaint reports, metrics and presentations for updates to senior management.
Ensure organize, file and archive supporting documentation for complaint records.
Data entry of CAPAs into appropriate system(s) (e.g., electronic database), including assurance of data quality in alignment with appropriate conventions.
Partner with stakeholders to support the robust documentation of root cause analysis, investigations, actions completed, and effectiveness checks performed for CAPA investigation and closeout. Will review all activities documented.
Faciliate project/team meetings for CAPAs and provide status updates.
Generate weekly and monthly CAPA reports, metrics and presentations for updates to senior management.
Perform training on complaint handling and CAPAs including investigation techniques, root cause analysis and RCA tools, effectiveness checks, CAPA report writing as needed.
Assist with and/or participate in internal audits, customer audits, ISO/TS audits, and regulatory audits as requested and help drive inspection readiness.
Assist in procedure development as requested.
Qualifications:
A minimum 3 years of medical device experience in a quality or regulatory position with demonstrated CAPA and complaint experience.
Engineering or Science Degree required.
Excellent oral and written communication skills and telephone presence/manner.
Ability to listen to customer concerns and improve customer relationships. Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone courtesy and professionalism.
Detail oriented - committed to accuracy, efficiency and consistency.
Able to multi-task with accuracy.
Proactive strategic thinker.
Flexible and persistent.
Able to function in a team environment and deliver on team objectives.
Able to influence and drive change.
Good conflict handling/negotiation skills able to interact with diplomacy in stressful situations.
Ability to independepently plan, organize, coordinate, manage, and execute assigned tasks.
Understands and can apply ISO 13485/9001 and FDA 21 CFR Part 820 requirements.
Understands CAPA principals including 8D concepts and root cause analysis tools.
Proficient in the use of a personal computer with intermediate level of keyboarding skills.
Estimated Salary: $20 to $28 per hour based on qualifications.
Salary to $80K DOE
DESCRIPTION:
This position is the process owner for the medical device complaint and CAPA systems at the manufacturing plant. This position receives, documents, maintains and reviews files on complaints reported on customers' marketed products in accordance with company policies and FDA regulations. This position champions the CAPA program by working with key players to ensure appropriate CAPAs are opened and addressed accurately in required timelines. Provides leadership in all areas of medical device complaint handling and CAPA management to ensure that tasks required are performed in an accurate and timely manner.
ESSENTIAL DUTIES AND
Responsibilities:
Ensures the accuracy and efficiency of complaint documentation from the initial receipt of a product complaint and opening of a complaint file to the final closure of the file.
Evaluates complaints for determining MDR events and documents rationale for not filing MDRs as applicable. Escalates complaints appropriately if the complaint is deemed reportable.
Assign or complete, review and approve investigations performed for complaints. Escalates complaint investigations to the CAPA program if required by company procedures.
Follow-up with customers and manufacturing and regulatory personnel to obtain additional information when necessary.
Perform final review for closure of complaint files to ensure accuracy, completeness and attention to detail.
Generate weekly and monthly complaint reports, metrics and presentations for updates to senior management.
Ensure organize, file and archive supporting documentation for complaint records.
Data entry of CAPAs into appropriate system(s) (e.g., electronic database), including assurance of data quality in alignment with appropriate conventions.
Partner with stakeholders to support the robust documentation of root cause analysis, investigations, actions completed, and effectiveness checks performed for CAPA investigation and closeout. Will review all activities documented.
Faciliate project/team meetings for CAPAs and provide status updates.
Generate weekly and monthly CAPA reports, metrics and presentations for updates to senior management.
Perform training on complaint handling and CAPAs including investigation techniques, root cause analysis and RCA tools, effectiveness checks, CAPA report writing as needed.
Assist with and/or participate in internal audits, customer audits, ISO/TS audits, and regulatory audits as requested and help drive inspection readiness.
Assist in procedure development as requested.
Qualifications:
A minimum 3 years of medical device experience in a quality or regulatory position with demonstrated CAPA and complaint experience.
Engineering or Science Degree required.
Excellent oral and written communication skills and telephone presence/manner.
Ability to listen to customer concerns and improve customer relationships. Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone courtesy and professionalism.
Detail oriented - committed to accuracy, efficiency and consistency.
Able to multi-task with accuracy.
Proactive strategic thinker.
Flexible and persistent.
Able to function in a team environment and deliver on team objectives.
Able to influence and drive change.
Good conflict handling/negotiation skills able to interact with diplomacy in stressful situations.
Ability to independepently plan, organize, coordinate, manage, and execute assigned tasks.
Understands and can apply ISO 13485/9001 and FDA 21 CFR Part 820 requirements.
Understands CAPA principals including 8D concepts and root cause analysis tools.
Proficient in the use of a personal computer with intermediate level of keyboarding skills.
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
