Quality Engineer

Integra Lifesciences Switzerland SAS

Publication date:
15 March 2023
Workload:
100%
Contract:
Permanent position
Place of work:
Girardet 29, 2400 Le Locle

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.

At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.

Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.

Regardless of geographic location, our commitment is to offer the following, whenever possible:

Benefit plans that meet all local statutory requirements
A range of programs that reflect typical local market practices
An opportunity for employees to tailor benefits to their specific needs
Benefits that balance employee’s short-term and long-term needs

Click HERE for more information regarding our benefits and total rewards program

Quality Engineer

Responsibilities

Ensures that adequate Quality support is provided to productions and to open projects / initiatives
Ensures that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
Ensures that quality activities for validation of new processes/ products are performed and documented according to procedures and within the defined timeline
Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan..)
Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline
Organize meeting for risk analysis activities and write risk management documentation
Ensures that GMP rules are known, understood and respected on the site
Ensure technical support to QC and laboratory department
Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Participates and supports internal and third party audits / inspections
Manages or participates to quality projects
Provides support to complaint investigation if required
Participate to procedure elaboration or update
Ensures that CAPA are managed and documented according to plans and in compliance with procedures
Ensures support to process improvement projects
Ensure resources are correctly filled in the project database

Qualifications

A minimum of a Bachelors Degree is required, preferable in Engineering, a Life Science or a related technical discipline.
Experience working in a Medical Device manufacturing environment is preferred.
Fluent in French and English
Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, EUMDR, 21 CFR part 820
Good communication, organizational, negotiation and interpersonal skills
Good analytical problem solving skills.
Use of Microsoft office tools
Good knowledge of statistical techniques