QC Inspector II

Provide support at the Costa Rica facility(ies) in Quality Control Engineering to plan, control, and ensure product, process, and validation quality in accordance with Quality regulations governing medical device manufacturing. Responsible for training other quality inspectors. Actively demonstrates and promotes high levels of discipline and rigor in quality standards. Additionally, will be a key support to the Quality Engineer.

This position is a T2 level (for internal use only)

What will you be doing?

Responsibilities:

• (Support the Quality Engineer with the Non-Conforming Product Control and discrepant material process (Internal Quarantine, deviations, and similar), including but not limited to:

• A- Ensure that non-conforming product (and discrepant material) is not inadvertently distributed.

• B- Support the Material Review Board (MRB).

• C- Disposition non-conforming (and discrepant) material in a timely manner and in compliance with all quality system requirements.

• D- Ensure prompt segregation and identification of non-conforming (and discrepant) product.

• Monitor Quality Control Engineering performance metrics such as those related to CAPAs, Quality Plans, NCRs, Internal Quarantine, deviations, etc.

• Provide support for continuous improvement processes in manufacturing processes, as well as inspection/quality processes.

• Participates in activities that allow the Quality Control Engineering area to prepare for internal and external audits.

• Coordinates and executes daily walk-throughs and audits in productive areas and other areas as required.

• Provides Quality Control support to production areas. Including, but not limited to:

• A- Quality Inspections

• B- Support as Pre-Release

• C- Support as MRB Clerk

• D- Support as Sterilization Process Release Coordinator, etc.

• (As required) Comply with all requirements, tasks, and obligations derived from our Quality Management System. This includes the adequate management of corrective and preventive action programs, strict adherence to all Quality standards, policies, and procedures.

• (As required) Comply with the implementation of occupational health and safety standards and programs established by the company, including following recommendations to perform work safely, wearing personal protective equipment, and informing the company about improvements to prevent incidents or occupational diseases.

• (As required) Responsible for safeguarding all documents, confidential information, equipment, tools, raw materials, products, or other assets directly related to their work area, in order to prevent incidents that affect productivity and product distribution.

Location: Costa Rica

Work Shift: NOC5 - L a S/10pm - 6am (Costa Rica)

What will you need to be successful?

Education:

• 50% or more of an engineering degree or a combination of experience considered equivalent

• Technical degree related to the position

Experience:

• At least 3 years of previous experience in the Medical Device industry.

• At least 3 years of experience in quality positions.

Language:

• English language: reading and writing 30% to 50%.

Competences:

• Organized person capable of working under pressure.

• Intermediate/advanced knowledge level in Microsoft Office

• Good interpersonal relationships.

• Dynamic and proactive person

• Assertive communication, negotiation, and conflict resolution skills.

• Ability to work as a team.

• Results orientation

• Detail orientation

• Integrity

• Initiative

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/ 

• Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.

• Work/Life Balance: Extra days off, birthday off, voluntary hours.

• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 

• Training: Training program, unlimited learning.

• Extra perks: employees association, and more…

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