Engr II, Quality
Job Description Summary
Responsible to perform complaint investigations and oversight complaint administration.
Job Description
Job Functions
- Execute complaint investigations, identify root causes, corrective action(s) and preventive action(s) applying problem-solving methodologies when applicable.
- Ensure compliance to requirements and consistency on content and timeliness of complaint investigations, engineering tasks, and device history records review for adequacy and compliance with applicable procedures.
-Cooperate and collaborate with management and peers to assess and improve the adequacy of the processes, which includes but is not limited to the remediation of complaints deficiencies noted in audits and/or inspections.
- Perform escalations to complaint related Product Risk Assessments, Risk Management Council. Document PRA assessments.
Administrator of the FPM/CPM process; including, collecting and analyzing data to identify trends, out of controls, escalations, top offenders when applicable.
-Participate in the rollout/implementation of any new CAPA solutions (tools, techniques, and/or process enhancements). This will also include providing training on a periodical basis for the relevant CAPA topics. Drive continuous improvement for complaint reduction as core Quality Business process/function(s)
- Other incidental duties assigned by Leadership
Education/Experience
- Bachelor's degree in industrial engineering, Mechanical or related field
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- 2 Years of previous related experience
- Experience in medical device or pharmaceutical industry preferred.
Required Skills
• Understanding of US Quality Systems Regulation (21 CFR Part 820), JPAL, CMDR, ISO13485.
• Good written and verbal English communication skills.
• Good computer skills in usage of MS Office.
• Basic understanding of statistical techniques.
• Good analytical, problem-solving skills and interpersonal skills Ability to manage competing priorities in a fast-paced environment Able to work independently and as part of a team.
• Ability to lead and manage multiple tasks in a timely manner.
• Ability to comply with the standards, regulations, procedures and quality manuals applicable to the company.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Required Skills
Optional Skills
.
Primary Work Location
DOM Santo Cristobal - Nave 15-Bachata
Additional Locations
Work Shift
DO Admin SH 45H 8AM-5PM (Dominican Republic)
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion