Quality Engineer
Company: SPR Therapeutics, Inc.
Location: Cleveland
Posted on: May 16, 2022
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Job Description:
Quality (or Senior Quality) Engineer SPR Therapeutics,
headquartered in the Highland Hills/Beachwood area, is a growing,
medical device development company specializing in pain management
through non-narcotic means. We are adding an experienced medical
device industry Quality Engineer or Senior Quality Engineer to
support the design and development of product enhancements as well
as innovative new products that are intended to improve patients---
lives. Some responsibilities of the Quality Engineer: -- Ensures
product development activities are conducted in accordance with
FDA---s QSR, ISO 13485 and internal Quality System requirements. --
Supports cross-functional development project teams to ensure that
new products and product changes are adequately evaluated/tested
with respect to requirements and the product Design History File is
complete. -- Develops and maintains risk management files through
active participation in risk management activities from product
conception through commercialization. -- Supports the needs of
contract manufacturers and product release activities. --
Contributes to sustaining the quality management system and the
software on which it is run, including validating routine software
updates. -- Supports and/or leads internal and external audits,
product complaint processing, CAPAs, and nonconformances.
Requirements: -- Bachelor---s degree in Engineering. -- 5-10 years
of Quality Engineer experience in medical device industry. --
Strong self-starter, effective team player, and detail-oriented
required. -- Understanding of US medical device regulatory
compliance requirements (ISO 13485 and FDA---s QSR). -- An
effective oral and written communicator with the ability to lead
meetings and clearly present ideas to employees and other
stakeholders. -- Ability to work efficiently and creatively in a
regulated industry. Why Join Our Team? -- Entrepreneurial work
environment --- A growth oriented and collaborative atmosphere in
the medical device industry -- Ability to work with game changing
technology. -- Competitive compensation and benefits -- Employee
Wellness Program
Keywords: SPR Therapeutics, Inc., Cleveland , Quality Engineer, Engineering , Cleveland, Ohio
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