Highlights
The main responsibilities of the line support quality engineer include, but are not limited to, the following: oversight of procedural readiness execution and remediation, measuring execution and effectiveness, track all quality improvement actions and projects in the area, monthly reporting on quality improvement activities, ownership of Quality Improvement projects (initiating Change Request / Change Order as necessary and overseeing the change was implemented and sustainable), and support to Investigations Engineers. Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
Numbers & Facts
| Location | Caguas, PR |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1998 |
| Website | http://www.kyyba.com/ |
Description
Job Title: (Quality Engineer_PR)
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Job Description
• Excellent written, verbal and interpersonal communication skills in both English and Spanish.
• Education – Bachelor’s Degree in Engineering field
Relevant experience in Quality and/or Compliance, preferably in medical device industry
• Understands product quality plans, documents, and quality systems.
• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other project team members.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
Exempt position. The line support quality engineer will serve as primary QA personnel supporting the day to day manufacturing operations in AVPR. The individual performing this role will have to create a strong teamwork with the line supervisor, investigations QE and ME service engineer to address all the opportunities found in the assigned manufacturing line. The incumbent will serve as the QA management representative in the manufacturing line, executing initiatives and working directly with the DL workforce. The main responsibilities of the line support quality engineer include, but are not limited to, the following: oversight of procedural readiness execution and remediation, measuring execution and effectiveness, track all quality improvement actions and projects in the area, monthly reporting on quality improvement activities, ownership of Quality Improvement projects (initiating Change Request / Change Order as necessary and overseeing the change was implemented and sustainable), and support to Investigations Engineers. Requires Bachelor degree, in Engineering. Minimum of 2 years of relevant experience in Quality and/or Compliance, preferably in medical device industry. Fully Bilingual (English/Spanish both oral and written). Knowledge of applicable US non-US applicable regulations. Knowledge and proficiency in the application and principles of Quality Engineering. Ability to effectively communicate cross-functionally to assist with resolving Quality issues. Excellent written, verbal and interpersonal communication skills. Ability to evaluate complex processes. Ability to interact effectively with all levels of employees.
Location: (Caguas,PR)
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.
Job Description
• Excellent written, verbal and interpersonal communication skills in both English and Spanish.
• Education – Bachelor’s Degree in Engineering field
Relevant experience in Quality and/or Compliance, preferably in medical device industry
• Understands product quality plans, documents, and quality systems.
• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other project team members.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
Exempt position. The line support quality engineer will serve as primary QA personnel supporting the day to day manufacturing operations in AVPR. The individual performing this role will have to create a strong teamwork with the line supervisor, investigations QE and ME service engineer to address all the opportunities found in the assigned manufacturing line. The incumbent will serve as the QA management representative in the manufacturing line, executing initiatives and working directly with the DL workforce. The main responsibilities of the line support quality engineer include, but are not limited to, the following: oversight of procedural readiness execution and remediation, measuring execution and effectiveness, track all quality improvement actions and projects in the area, monthly reporting on quality improvement activities, ownership of Quality Improvement projects (initiating Change Request / Change Order as necessary and overseeing the change was implemented and sustainable), and support to Investigations Engineers. Requires Bachelor degree, in Engineering. Minimum of 2 years of relevant experience in Quality and/or Compliance, preferably in medical device industry. Fully Bilingual (English/Spanish both oral and written). Knowledge of applicable US non-US applicable regulations. Knowledge and proficiency in the application and principles of Quality Engineering. Ability to effectively communicate cross-functionally to assist with resolving Quality issues. Excellent written, verbal and interpersonal communication skills. Ability to evaluate complex processes. Ability to interact effectively with all levels of employees.
Location: (Caguas,PR)
Disclaimer:
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665
Rewards:
Medical, dental, vision
401k
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client
SELECT AWARDS
- An INC 5000 company for 10 years
- Corp! Michigan Economic Bright Spots
- Crain’s Detroit Business Top Staffing Service Companies in Detroit
- TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
- Best of MichBusiness winner in HR Wizards & Partnerships
- Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
- 101 Best & Brightest Companies to Work for in Michigan
About Company
Kyyba group of companies are privately held and specialize in staff augmentation, application software and project solutions. In operation for more than 15 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enables us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.
Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.