Company: SanaVita Medical
Posted on: February 19, 2021
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
- Performs Receiving, First Article and In-process
- Integrates customer label designs into Bartender software
program and coordinates label printing and verification with
- 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
- 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
- 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
- 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
- Demonstrated ability to organize and manage small to
medium-sized projects and effectively participate in
- 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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