Sr. Quality Engineer

Stryker•Arroyo, PR

19h•Onsite

About The Position

Basic Function: Responsible for developing, applying, revising, and maintaining quality standards for processing raw materials and/or components into partially finished and/or finished products.

Requirements

Strong analytical skills and presentation skills
Effective interpersonal skills
Blueprint/engineering schematic reading and interpretation
Basic inspection techniques
Basic PC skills
Bilingual (English and Spanish)
5+ years experience in Quality Assurance Engineering or related functional area
Knowledge of inspection methods in the design and production of electromechanical and/or mechanical equipment.
B.S. in engineering or engineering related discipline.

Nice To Haves

Licensed Engineer (EIT or PE) desired
Some Quality Assurance training desired

Responsibilities

Continuously comply with all regulatory related requirements.
Will conduct Internal and External audits.
May train others in Quality Assurance/GMP/FDA-QSR related topics.
Design and/or implement methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment: Statistical process control, Incoming part/product inspection criteria, Automated testing, Functional gauging, Productivity improvements
Stop further processing in the event of encountering non-conforming products condition.
May design and/or specify inspection and testing mechanisms and equipment.
Prepare documentation for inspection/testing procedures.
May support vendor management issues: Problem solving, Auditing, Inspection techniques/equipment, Training.
May interact with suppliers either telephonically or in person to develop and standardize inspection methods and or techniques to ensure components compliance with specifications.
May interact with customers either telephonically or in person to solve reliability issues and/or answer general product questions: Complaint investigation/problem solving, Customer training, Design improvements and Special Orders.
May assist during new product development. Validation support for product, processes, packaging, software, and sterilization.
Analyze reports and/or returned products and recommends corrective action.
Will conduct failure analysis of products and processes: Problem solving efforts, Reliability design improvements, Product failure trending, Training.
May work from verbal and/or written instructions.
Commit to the EHS policy.
Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake Proofing, etc)
Actively participate and lead on new product development teams to support product and process design and development activities.
Lead and participate in the development and improvement of the manufacturing processes for existing and new product.
Review and approve inspection plans, routers and product drawings.
Lead in development, review and approval of process and equipment validation/qualifications.
May coordinate the activities of one or more Quality Control Inspectors and/or Technicians.
May evaluate the performance of one or more Quality Control Inspectors and/or Technicians based on pre-established performance parameters.
Serves as mentors to QA Engineers and/or Associated QA Engineers