Descripción del puesto

Requisitos del puesto

• 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

Cómo debería ser tu experiencia:

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..

Competencias