Quality Engineer 1 - Hologic
Louisville, CO
About the Job
Quality Engineer 1
Louisville, CO, United States
Why Hologic?
Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.
Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.
Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
What to Expect:
Performs evaluations, investigations, and root cause analyses in relation to post market feedback and complaints from the field for energy devices and vessel sealers. Assists in processing and evaluating product returns for manufactured and distributed products as required by applicable regulations, standards, and internal procedures. Processes and owns complaints as a facilitator from initiation to closure to ensure validity of the complaint and adequate information and codes are assigned to the records. Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact. Participates in teams to implement improvements or corrections based on the results of complaint investigations.
Works on problems of minor scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships. Performs investigations in the field at customer sites partnering with field-based teams, including sales and service. As applicable, lead project to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
What we expect:
+ Excellent computer skills including ability to use word processing, spreadsheet programs and databases
+ Excellent technical writing skills with ability to write quality assurance reports and details procedures
+ Excellent problem solving and root cause analysis skills (use of root cause analysis tools)
+ Strong analytical skills including trend and statistical analysis
+ Ability to actively participate on the execution of projects, keep to timelines and prioritize activities
+ Ability to participate in troubleshooting and solving of technical issues across multiple assays and platforms
+ Ability to analyze data and come to valid scientific conclusions
+ Ability to document technical work and lead investigations and improvements in a GMP environment
+ Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
+ Strong collaboration and interpersonal skills
+ Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements is beneficial.
+ Certified Quality Engineer is beneficial.
Education & Experience:
+ Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with minimum job-related experience of 1-3 years
+ Preferred Minimum Technical/Advanced Degree: 0-2 Years with Technical Bachelor’s Degree, 0-2 Years with Master’s Degree
+ Experience in an FDA regulated industry is beneficial.
The annualized base salary range for this role is $62,900 to $98,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._
#LI-PR1
Louisville, CO, United States
Why Hologic?
Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.
Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.
Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
What to Expect:
Performs evaluations, investigations, and root cause analyses in relation to post market feedback and complaints from the field for energy devices and vessel sealers. Assists in processing and evaluating product returns for manufactured and distributed products as required by applicable regulations, standards, and internal procedures. Processes and owns complaints as a facilitator from initiation to closure to ensure validity of the complaint and adequate information and codes are assigned to the records. Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact. Participates in teams to implement improvements or corrections based on the results of complaint investigations.
Works on problems of minor scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships. Performs investigations in the field at customer sites partnering with field-based teams, including sales and service. As applicable, lead project to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
What we expect:
+ Excellent computer skills including ability to use word processing, spreadsheet programs and databases
+ Excellent technical writing skills with ability to write quality assurance reports and details procedures
+ Excellent problem solving and root cause analysis skills (use of root cause analysis tools)
+ Strong analytical skills including trend and statistical analysis
+ Ability to actively participate on the execution of projects, keep to timelines and prioritize activities
+ Ability to participate in troubleshooting and solving of technical issues across multiple assays and platforms
+ Ability to analyze data and come to valid scientific conclusions
+ Ability to document technical work and lead investigations and improvements in a GMP environment
+ Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
+ Strong collaboration and interpersonal skills
+ Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements is beneficial.
+ Certified Quality Engineer is beneficial.
Education & Experience:
+ Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with minimum job-related experience of 1-3 years
+ Preferred Minimum Technical/Advanced Degree: 0-2 Years with Technical Bachelor’s Degree, 0-2 Years with Master’s Degree
+ Experience in an FDA regulated industry is beneficial.
The annualized base salary range for this role is $62,900 to $98,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._
#LI-PR1
Source : Hologic