Quality Assurance Engineer

Job Description

The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently produce medical devices that meet specifications. This role supports and ensures compliant execution of New Product Introduction and manufacturing Life Cycle Management activities and drive continuous improvement activities.

Accountabilities

• Ensure process risk assessment files are in accordance with ISO 14971.
• Ensure validations and verifications are robust, monitoring activities are performed and analyzed and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Monitor and track non-conformances, and lead continuous improvement projects.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document and evaluate production non-conformances, and drive root cause analysis.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action (in different roles)
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.

Job Requirements

• Ensure process risk assessment files are in accordance with ISO 14971.
• Ensure validations and verifications are robust, monitoring activities are performed and analyzed and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Monitor and track non-conformances, and lead continuous improvement projects.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document and evaluate production non-conformances, and drive root cause analysis.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action (in different roles)
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.

Operating Company

Nobel BiocareEnvista 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.