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Quality Engineer

Company: SanaVita Medical
Location: Telford
Posted on: February 19, 2021

Job Description:

Who we are: SanaVita Medical provides the contract manufacturing and medical device processing services needed to bring innovative solutions to market. From finishing and assembly, packaging and labeling, sterilization management, and regulatory registration and compliance, SanaVita Medical provides services that are perfectly aligned with a vital supply chain.
What we're looking for: Based in our Telford, PA facility, the Quality Engineer develops, coordinates, and implements various activities pertaining to the SanaVita Medical Quality Management System (QMS) in accordance with 21 CFR Parts 210, 211 and 820, ISO 13485:2016, customer requirements, and applicable standards.
What you'll 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.
  • Performs Receiving, First Article and In-process inspections.
  • Integrates customer label designs into Bartender software program and coordinates label printing and verification with Document.
  • 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: Specifications, Procedures, Work Instructions, Equipment Qualification, Validation Protocol / Reports, Receiving Inspection, and Inspection / Test Method etc. 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 requested.
  • Performs statistical data analysis utilizing statistical software (Minitab and Excel).
  • Compiles data requested for Management Revie.
  • Supports FDA Inspections, Customer and Third-party Audits as required.
  • May perform internal quality.
  • Assists in training of new or existing personnel.
  • Follows established safety requirements and adheres to Health, Safety & Environmental Management System.
  • Performs other job-related responsibilities as assigned.
    Who you are:
    • Associate degree (or higher) related to life sciences or equivalent.
    • Strong problem solving and organizational skills5 years of experience in a related industry or regulated environment (e.g., ISO 13485, 21 CFR Part 820) in one of the following functions: Quality Control, Manufacturing, and Product Development.
    • Knowledge of applicable regulatory standards such as 21 CFR Parts 210, 211, 820 and ISO 13485:2016.
    • 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.
      Why join us: We promote a collaborative, high energy and fast-paced environment. Using fact-based data, our team members strive to constantly improve our processes and products. We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.
      This position includes a compensation package that includes a base salary plus incentive based on company performance. We offer a comprehensive benefits package, medical with Rx, life insurance and 401(k). SanaVita Medical is an Equal Opportunity Employer. SanaVita Medical participates in E-Verify as appropriate in accordance with Company guidelines and federal or state law.
      SanaVita Medical utilizes pre-employment drug testing, background checks and criminal history checks in a manner consistent with all federal, state and local regulations.

Keywords: SanaVita Medical, Bethlehem , Quality Engineer, Engineering , Telford, Pennsylvania

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