Remote Quality Engineer

Apex Systems Remote
remote engineer software medical solution regulatory apex maintenance procedures software development management supplier quality remote
November 22, 2022
Apex Systems
Columbus
CONTRACTOR
Job#: 1312720


Job Description:


Apex Systems is seeking a Supplier Quality Engineer to work remotely within the United States to support a Fortune 100 Medical Device Company.


Duties:

Location:
100% remote.

Quality Engineering participates and supports the effective development, deployment and maintenance of computing and information services. This function anticipates, plans and delivers solution and strategies that enable operations and drive business value.

This role works cross-functionally in the development and maintenance for developing, implementing, and supporting eQMS applications and eQMS systems required to achieve the company's business objective.

This role supports the development of quality policies, procedures, and processes and supporting systems and assess processes and practices for regulatory risk and conformance to quality standards and working with business and quality leaders to implement improvements.

Demonstrates knowledge of quality systems.
Demonstrates knowledge of software development techniques.

Demonstrates general understanding of hardware/software platforms including but not limited to operating systems, databases, application servers, web servers and integration technologies.

Demonstrates an understanding of quality concepts such as: documentation systems, change control, electronic records, corrective actions and internal audits.
Plans and executes system implementations that ensure success and minimize risk of system outages or other negative production impacts.
Demonstrates conceptual knowledge of architecture standards.
Demonstrates knowledge of software development, life cycle, modeling of business processes, application design patterns, business/functional documents.
Demonstrates comprehensive knowledge of regulatory regulations, standards and operating procedures in their respective areas.
Supports maintenance of quality system requirements, including quality metrics reporting, trending review preparation, and training.

Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Supports Quality Assurance, Quality Control, and Regulatory functions as necessary.



Skills:

Role Overview


The enterprise electronic Quality Management System (eQMS) will be a SaaS configured solution to manage complaints, non-conformances, investigations, corrective actions, audits, change control, document management and supplier quality management.

It will be used across both Medical and Pharmaceutical segments and will include integrations with applications in both the Medical and Pharmaceutical segments for Master Data and Analytics.

This role will focus on the implementation of these processes in the new eQMS platform.

Role Accountabilities include

Support an eQMS implementation for multiple business processes.
Work directly with the subject matter experts and consultants from the implementation vendor.

Accountable for script development, testing and validating the new eQMS processes by working closely with software validation quality business owner teams and process teams.

Manage the scope and deliverables for process streams leveraging software development lifecycle methodologies.
Conduct the requirements elicitation process and ensure solution delivery meets business requirements while leveraging existing solution capabilities wherever possible.
Maintain relationships with Quality and Regulatory business process leads and user groups.


Education:
4 years of experience
BA, BS or equivalent experience in related field, preferred.
Experience leading cross functional teams and IT projects.
Experience working in an FDA regulated environment supporting quality is preferred.
Experience working with a SaaS provider is recommended.
Language

Skills:

Ability to read, analyze and interpret general business and professional journals, and technical procedures.
Ability to write and execute test scripts and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Knowledge and previous experience with eQMS software electronic systems

EEO Employer

Apex Systems is an equal opportunity employer.

We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.


Employee Type:
Contract


Remote:
Yes


Location:
Columbus, OH, US


Job Type:
Engineering and Technicians


Date Posted:
November 21, 2022

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