Description

About the role:

The Quality Assurance Engineer develops, coordinates, and implements various activities pertaining to the effective management of the SanaVita Medical Quality Management System (QMS) in accordance with 21 CFR Parts 810, 811, 820, ISO 13485:2016, customer requirements, and applicable standards.

What you will do:

• Performs and documents Nonconformances, Deviations, Returned Material Authorizations (RMAs), and Supplier Corrective Action Requests (SCARs) as applicable.
• Acts as lead on assigned CAPA requests to investigate, develop, drive and document required actions and closure within prescribed timelines.
• May assist with Receiving, First Article and In-process inspections.
• Integrates customer label designs into software program and approves printed labels for manufacturing.
• Assists with customer complaint investigations, performs root cause analysis, and develops corrective and preventive actions as requested. Works with customers to provide required technical support and information regarding the investigation.
• Authors documents: Test Method Validation Protocols and Reports, Inspections (Incoming, in process, Final), Specifications, Procedures, Work Instructions, as required.
• Assists with completion of equipment qualification, process validation protocols and reports.
• Participates in customer meetings and assists Program Management in the transition of new Customer designed products into production when requested.
• Reviews/approves records pertaining to the controlled production environment (cleanroom logs, monitoring reports).
• Reviews calibration certificates as needed.
• Performs statistical data analysis utilizing statistical software (Minitab and Excel).
• Compiles data requested for Management Review.
• Supports FDA Inspections, Customer and Third-party Audits as required.
• May perform internal or supplier audits.
• Assists in training of new or existing personnel.

Qualifications

Who you are:

• Bachelor’s degree (or higher) related to life sciences or equivalent.
• 5 years of experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Parts 810, 811 and 820) in one of the following functions: Quality Control or Product Development.
• Knowledge of quality management standards, specifically ISO 13485:2016 and FDA Regulations 21 CFR Parts 210, 211 and 820.
• Detail-oriented, self-starter with high attention to detail and ability to work on and coordinate multiple projects/assignments
• Demonstrated ability to organize and manage small to medium-sized projects and effectively participate in cross-functional teams
• Hands-on experience with test equipment including the ability to understand the working mechanisms and methodologies
• Strong written and verbal communication skills
• Strong problem solving and organizational skills
• Intermediate to advanced knowledge of MS Office Suite.
• Excellent customer service focus and professionalism.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)