Job Overview

A Quality & Reliability Engineer Supervisor uses their engineering skills to assist in issues related to the Quality of the product. This job also involves leveraging advanced technical skills to resolve issues related to the product to meet quality goals. 

Job Requirements

• Apply experience in process compliance and auditing. Proficient problem-solving and research skills (attention to detail and report writing).
• Development multiple tasks and accomplish them in a timely manner.
• Ability to work on own initiative with remote administration.
• Apply a skilled Lead Auditor with experience in conducting quality system audits.
• Apply excellent communication and interpersonal skills.
• Organized with a strong ability to prioritize tasks and work on the initiative.
• Apply knowledge of ISO 13485 and FDA quality requirements. 
• Develop and implement world class quality processes in the Quality System in 
  support of business requirements, working closely with site Quality leaders. 
  • As a site matures (such as moving from component manufacturing to finished device 
  manufacturing) lead the development of the site Quality System to meet additional 
  requirements. 
  • Ensure all aspects of the sites QMS (Management Reviews, Internal Audits and 
  Supplier Management, etc.) comply with global quality procedures. 
  • Represent quality at customer meetings; represent the Global Quality organization 
  and be able to outline the Creganna Quality system and principles as part of business 
  proposals, QBRs, etc. 
  • Responsible for scheduling, planning, conducting, communicating, and reporting on 
  global internal audit results. 
  • Communicate closely with the Project Management Office to be aware of NPI / 
  transfers to sites that could affect the QMS, and plan for such changes. 
  • Support the implementation of electronic quality and other systems that could affect 
  the QMS. 
  • Serve as quality approver on engineering change orders (ECO) / document change 
  orders (DCO), training matrices and other documents as requested

What your background should look like

Core Competencies  
• Technical Learning - Picks up on technical things quickly; can learn new skills and 
knowledge; is good at learning new industry, company, product, or technical 
knowledge; does well in technical courses and seminars. 
• Problem Solving- Uses rigorous logic and methods to solve difficult problems with 
effective solutions; probes all fruitful sources for answers; can see hidden problems; 
is excellent at honest analysis; looks beyond the obvious and doesn’t stop at the first 
answers. 
• Ethics and Values - Adheres to an appropriate (for the setting) and effective set of 
core values and beliefs during both good and bad times; acts in line with those 
values; rewards the right values and disapproves of others; practices what he/she 
preaches. 
• Action Oriented - Enjoys working hard; is action oriented and full of energy for the 
things that he/she sees as challenging; not fearful of acting with a minimum of 
planning; seizes more opportunities than others. 
• Job Specific Knowledge, Skills and Abilities 
Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Quantity of 
returned product (RMAs), DPPM, DLPM.   
Skills- Skills are the proficiency to perform a certain task.  
Abilities- Abilities are an underlying, enduring trait useful for performing tasks (oral 
comprehension, understanding information and ideas). 
• Language: Bilingual English (Advanced) / Spanish. 
• Experience in process compliance and auditing. Proficient problem solving and 
research skills. 
• Manage multiple tasks and accomplish them in a timely manner. 
• Ability to work on own initiative with remote administration. 
• Act as a skilled Lead Auditor with experience in conducting quality system audits. 
• Excellent technical "hands-on" skills. 
• Excellent communication and interpersonal skills. 
• Highly organized with strong ability to prioritize tasks and work on initiative. 
• Ability to evaluate information gathered from observation, experience, reasoning 
and/or communication. Demonstrated clarity, accuracy, independent judgment and 
thoroughness. 
• Strong knowledge of ISO 13485 and FDA quality requirements. 
• Excellent attention to detail and report writing. 
• Based in Costa Rica, but have the willingness to travel up to 20% of the time.. 

Competencies