Quality Engineer

Posted 15 Days Ago
Be an Early Applicant
México, Mexicali, Baja California
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
Quality Engineer responsible for reviewing processes, creating validation protocols, tracking validations, providing statistical support, and supporting improvement projects in the medical industry. Must have knowledge of QMS, ISO Standards, and manufacturing processes.
Summary Generated by Built In


Job Description:

Review new and modified processes.

  • Analysis for validation or revalidation requirements (IQ/OQ/PQ).

  • Validation protocols creation.

  • Validations tracking.

  • Support on validation corrective actions required.

  • Report validation results.

Statistical support on production processes

  • Required SPC tool evaluation.

  • Report validation results.

  • Capability studies implementation.

  • Gage R&R implementation.

  • Suport to implement methods/altern sampling.

  • Support to eliminate destructive tests.

  • Support to improvement projects.

Job Requirements:

Experience

  • Industrial Engineer, Mechanical Engineer, Electronics Engineer, or similar.

  • Medical Industry Experienced.

  • QMS and ISO Standard Knowledge (ISO13485 and/or FDA GMP)

  • Manufacturing Process 3-year-experienced

  • New Product development/Process transfers/Process improvement experienced.

  • English about 85% Preferred (spoken, written, read)

Operating Company:

Spark

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

The Company
Brea, California
1,933 Employees
On-site Workplace

What We Do

Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its partners deliver the best possible patient care through industry-leading products, solutions, and technology. Our comprehensive portfolio covers a wide range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions, as well as improving the aesthetics of the human smile.

Our differentiated combination of continuous improvement, a bias toward action and innovation, and a deep respect for the more than one million professionals we serve embolden us to champion dental professionals like no one else can.

The operating companies that form Envista, including Nobel Biocare, Implant Direct, Ormco, DEXIS, Kerr, Metrex, and more represent more than 125 years of dental industry excellence. These brands meet the end-to-end needs of dental professionals worldwide.

We are committed to helping dental professionals improve their patients’ lives by digitizing, personalizing, and democratizing oral care. Every day, our products and solutions are accelerating the future of dentistry. Operating with high sustainability standards guides our decision-making so that we can deliver enhanced outcomes for our people, the environment, and communities.

View our Environmental, Social, and Governance report at https://bit.ly/Envista2022ESG to learn more about our commitment to sustainability.

Learn more at www.envistaco.com

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