Plastic Processing Unit - Quality Technician 1

3 weeks agoGuayama, Puerto Rico

COVID-19 vaccination requirements
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.
Why join Stryker? We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.
Why regulatory affairs/quality assurance at Stryker?
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team:

Job Description

The following is not intended to represent an all inclusive list of job responsibilities, but to outline the ESSENCIAL FUNCTIONS of the position.

Basic Function:

  • Under direct supervision performs a substantial variety of moderately complex to highly complex inspection tasks using standard procedures, gauges, tools, computers and equipment.

  • Continuously fully comply with all ISO, FDA regulations and QSR and other quality standard requirements,
  • Perform inspections of manufacturing processes of Injection Molded components and process raw materials.
  • Ensure in process, and/or finished components meet company and regulatory standards.
  • Participates in training others on inspection techniques and procedures.
  • Work from engineering prints, task instruction or quality inspection procedures to perform accurate checks and tests.
  • Comply with documentation and regulatory procedures and policies.
  • Interact with engineers, supervisors and non-exempt / exempt personnel, to resolve in process products issues.
  • Work from written and/or verbal directions/instructions.
  • Assess compliance of processes to standards established.
  • Assist in developing and using standard inspection procedures.
  • Participate in or lead QA improvement projects, audits.
  • Generate and investigate non-conformance reports under the supervision of the Quality Engineers.
  • Ensure proper use of inspection routines for measuring components.
  • Inspect components through validated measuring routines on OGP optical measuring system.
  • Inspect calibration certificates, labeling and literature to ensure regulatory compliance.
  • Verify periodically ECA parameters to ensure room compliance to procedure environmental controls.

Supervisory Responsibilities:
  • N/A

Physical Requirements:
  • Medium Work: Exerting up to 50 pounds of force occasionally and/or up to 20 pounds of force constantly to move objects.
  • Very good visual acuity.
  • Ability to work with and inspect very small objects and/or tools and component parts.

Mental Requirements:
  • Observe and note minute inconsistencies.
  • Follow and explain detailed instructions and inspections procedures.
  • Explain detailed documentation accurately.
  • Communicate product and/or component part deficiencies to supervisory or engineering personnel.
  • Prioritize work effectively.
  • Identify routine product issues using independent judgment and inspection equipment.
  • Address problems independently based on limited information.

Required Skills:
  • Read, write, and speak English.
  • Math and measurement skills.
  • Ability to select and operate appropriate measurement equipment accurately.
  • Procedures/engineering drawings reading and interpretation.
  • Routine inspection techniques.
  • Basic Computer Skills

Required Experience:
  • 6-12 months experience in manufacturing processes for medical devices or other regulated environment such as ISO, FDA, and Pharmaceutical etc.
  • At least 2 years close tolerance quality inspection.

Required Education and Training:
  • High School Diploma.
  • Quality/Mechanical skills recognition desired.

Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at
About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting

Job ID: Stryker_Combined-vRJu0nRWrOrH