Quality Engineer

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.