Quality Engineer I - Exempt - LanceSoft Inc
Santa Ana, CA 92705
About the Job
Must Have:
1. Investigation and root cause analysis skills
Anatomy and physiology
Cardiovascular Diseases
Complaint Handling Analyst
Complaint Investigation Analyst
Highly proficient in Microsoft Excel, Word, PowerPoint
Strong Communication Skills
Technical Writing
Nice to Have:
Complaint Trending
Data Analysis
Experience in Heart Valve Therapy
Risk Management
JOB DESCRIPTION
HM's Top Needs:
1. Experience in Complaint handling, complaint investigation and root cause analysis for Medical Devices
2. Ability to work cross-functionally, and deliver consistent outputs to meet set targets.
3. Strong knowledge of Cardiovascular diseases, use of heart valves and catheters
Education Required: Bachelor’s degree in Science/Engineering
Years’ Experience Required: minimum 2 years
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Work Location:
Do they need to be local to any MDT office and if so where? Yes, local to Santa Ana, CA or Orange County area
Does this person need to be on site? If so, full time or part time? Flex i.e. part time on site.
Responsibilities may include the following and other duties may be assigned.
Conducts complaint investigations for Structural Heart devices. This includes performing intial assessment to create appropriate tasks or technical assessments in the Global Complaint Handling (GCH) system, for example - DHR reviews, Manufacturing assessment, R&D assessment ,etc. Performing thorough review of these assessments by working with the cross-functional teams (like Medical Safety, Manufacturing, Operations Quality, R&D, Design Assurance and Customer Quality Teams) across multiple sites and time zones globally. Summarizing the results of these assessment into the complaint investigation summary in a timely manner to ensure timely closure of the overall event.
To be able to consistently close complaint investigations to meet weekly target volumes. Ensuring timely completion of complaint investigations to sustain a compliant timeliness metric/KPI for the entire Operating unit.
Presenting complaints on a weekly basis and escalating events that meet certain criteria. To be able to communicate complaint information across all levels in the organization.
Supporting regulatory submissions and regulatory inquries on complaints by working closely with Customer Quality Experience Management team (CQXM) and providing complaint data as requested.
Ability to present the complaint investigation in an audit when needed.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on the post market quality team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts across all levels within the operating unit.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.
1. Investigation and root cause analysis skills
Anatomy and physiology
Cardiovascular Diseases
Complaint Handling Analyst
Complaint Investigation Analyst
Highly proficient in Microsoft Excel, Word, PowerPoint
Strong Communication Skills
Technical Writing
Nice to Have:
Complaint Trending
Data Analysis
Experience in Heart Valve Therapy
Risk Management
JOB DESCRIPTION
HM's Top Needs:
1. Experience in Complaint handling, complaint investigation and root cause analysis for Medical Devices
2. Ability to work cross-functionally, and deliver consistent outputs to meet set targets.
3. Strong knowledge of Cardiovascular diseases, use of heart valves and catheters
Education Required: Bachelor’s degree in Science/Engineering
Years’ Experience Required: minimum 2 years
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours
Work Location:
Do they need to be local to any MDT office and if so where? Yes, local to Santa Ana, CA or Orange County area
Does this person need to be on site? If so, full time or part time? Flex i.e. part time on site.
Responsibilities may include the following and other duties may be assigned.
Conducts complaint investigations for Structural Heart devices. This includes performing intial assessment to create appropriate tasks or technical assessments in the Global Complaint Handling (GCH) system, for example - DHR reviews, Manufacturing assessment, R&D assessment ,etc. Performing thorough review of these assessments by working with the cross-functional teams (like Medical Safety, Manufacturing, Operations Quality, R&D, Design Assurance and Customer Quality Teams) across multiple sites and time zones globally. Summarizing the results of these assessment into the complaint investigation summary in a timely manner to ensure timely closure of the overall event.
To be able to consistently close complaint investigations to meet weekly target volumes. Ensuring timely completion of complaint investigations to sustain a compliant timeliness metric/KPI for the entire Operating unit.
Presenting complaints on a weekly basis and escalating events that meet certain criteria. To be able to communicate complaint information across all levels in the organization.
Supporting regulatory submissions and regulatory inquries on complaints by working closely with Customer Quality Experience Management team (CQXM) and providing complaint data as requested.
Ability to present the complaint investigation in an audit when needed.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on the post market quality team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts across all levels within the operating unit.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.
Source : LanceSoft Inc
