Quality Engineer-Complaints Job in Pleasanton 94588, California US
Description: The primary responsibility of this position is management of the complaint system including the investigation, analysis, resolution, trending and corrective action of all complaints.
Specific responsibilities include; preparing and analyzing complaint trend data, maintaining the complaint files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness.
Other duties may be assigned.
Reports To: Director of Quality Assurance
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all-inclusive of the duties and responsibilities for this position.
- Establishes and maintains complete complaint files for all customer complaints
- Responsible for investigating complaints and/or managing resources necessary to investigate complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
- Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
- Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
- Communicates directly with customer to resolve complaints
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
- Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations
- Manages medical device reporting regulations (MDR’s)
Experience, Education, Training, Traits:
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline
- Minimum of 3 years of quality systems experience in FDA regulated medical device manufacturing environment(s) with 2 years in complaint system management
- Experience with medical device adverse events, complaint trending and CAPA systems
- Knowledge of QSR, 13485:2003, and 14971:2007
- Problem solver.
- Self-directed.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Language and Verbal Skills
- Good oral and written communication skills.
- Ability to write reports, data analysis, and business correspondence.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
Math Skills
· Ability to work with mathematical concepts such as probability and statistical inference.
· Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
· Ability to use MS Excel to perform calculations and interpret results/data.
Analytical and Reading Skills
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to read technical literature and documents and extract important concepts.
Physical Requirements
While performing the duties of this job, the employee is regularly required to sit. The employee will be required to use a computer for up to 8 hours consecutively. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls and talk or hear. The employee is occasionally required to reach with hands and arms and be mobile.
The employee may be required to lift up to 25 pounds, or move equipment that may weigh in excess of 100 pounds.
Specific vision abilities required by this job include close vision and color vision.
This position is office based and may require travel up to 10% of the time. Travel may be overnight and may require a passport.
Work Environment
The noise level in the work environment is usually moderate. Some work will be required to be performed in animal and clinical laboratories, where the employee must employ standard techniques to protect against chemical and biological hazards. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.
Description: The primary responsibility of this position is management of the complaint system including the investigation, analysis, resolution, trending and corrective action of all complaints.
Specific responsibilities include; preparing and analyzing complaint trend data, maintaining the complaint files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness.
Other duties may be assigned.
Reports To: Director of Quality Assurance
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all-inclusive of the duties and responsibilities for this position.
- Establishes and maintains complete complaint files for all customer complaints
- Responsible for investigating complaints and/or managing resources necessary to investigate complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
- Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
- Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
- Communicates directly with customer to resolve complaints
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
- Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations
- Manages medical device reporting regulations (MDR’s)
Experience, Education, Training, Traits:
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline
- Minimum of 3 years of quality systems experience in FDA regulated medical device manufacturing environment(s) with 2 years in complaint system management
- Experience with medical device adverse events, complaint trending and CAPA systems
- Knowledge of QSR, 13485:2003, and 14971:2007
- Problem solver.
- Self-directed.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Language and Verbal Skills
- Good oral and written communication skills.
- Ability to write reports, data analysis, and business correspondence.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
Math Skills
· Ability to work with mathematical concepts such as probability and statistical inference.
· Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
· Ability to use MS Excel to perform calculations and interpret results/data.
Analytical and Reading Skills
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to read technical literature and documents and extract important concepts.
Work Environment
The noise level in the work environment is usually moderate. Some work will be required to be performed in animal and clinical laboratories, where the employee must employ standard techniques to protect against chemical and biological hazards. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.
Description: The primary responsibility of this position is management of the complaint system including the investigation, analysis, resolution, trending and corrective action of all complaints.
Specific responsibilities include; preparing and analyzing complaint trend data, maintaining the complaint files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness.
Other duties may be assigned.
Reports To: Director of Quality Assurance
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all-inclusive of the duties and responsibilities for this position.
- Establishes and maintains complete complaint files for all customer complaints
- Responsible for investigating complaints and/or managing resources necessary to investigate complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
- Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
- Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
- Communicates directly with customer to resolve complaints
- Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
- Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations
- Manages medical device reporting regulations (MDR’s)
Experience, Education, Training, Traits:
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline
- Minimum of 3 years of quality systems experience in FDA regulated medical device manufacturing environment(s) with 2 years in complaint system management
- Experience with medical device adverse events, complaint trending and CAPA systems
- Knowledge of QSR, 13485:2003, and 14971:2007
- Problem solver.
- Self-directed.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Language and Verbal Skills
- Good oral and written communication skills.
- Ability to write reports, data analysis, and business correspondence.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
Math Skills
· Ability to work with mathematical concepts such as probability and statistical inference.
· Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
· Ability to use MS Excel to perform calculations and interpret results/data.
Analytical and Reading Skills
· Ability to define problems, collect data, establish facts, and draw valid conclusions.
· Ability to read technical literature and documents and extract important concepts.
Work Environment
The noise level in the work environment is usually moderate. Some work will be required to be performed in animal and clinical laboratories, where the employee must employ standard techniques to protect against chemical and biological hazards. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.