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Quality Engineer

Company: Syncroness
Location: Broomfield
Posted on: November 14, 2021

Job Description:

Complex problems. Inspired solutions. Complex problems. Inspired solutions. Job Title: Quality Engineer Who we areSyncroness provides inspired solutions to highly complex business and technical problems. We focus on accelerating time-to-market and ensuring a profitable outcome for our clients. By providing a full complement of engineering services aligned to the entire product lifecycle, Syncroness enables companies to accelerate product development and drive more predictability and productivity into their businesses. Working with Syncroness, companies gain the critical insights necessary to develop products that make a difference and create a better world. We provide proven value and predictable results in demanding and regulated markets by employing our core competencies in:Project managementProduct and System EngineeringCore Engineering disciplinesKnowledge integrationNPD and Sustaining Engineering What we are looking for:The Quality Engineer leads the development, implementation, and maintenance of the quality engineering methodologies, systems, and practices which meet Medical Device/Combination Product regulatory standards concentrating on the application of Design Control, Risk Management and incoming component quality management. Essential Duties and Responsibilities include the following. Other duties may be assigned.

Builds and supports the Quality Engineering function by providing intelligence, discipline, problem solving and collaborative skills that can improve designs and processes.
Investigates non-conforming events and product failures as they relate to Design Controls to drive product and process improvements with the objective of compliance safety and high customer satisfaction.
Authors and/or maintains the Design Control portion of the Quality Management System (QMS) that encompasses all the Standard Operating Procedures (SOPs) that are required by the Federal Drug Administration (FDA) for medical device/combination products.
Ensures designs, tests, risk analysis, and human factors activities for the companys products are safe and effective for use.
Ensures risk management is effective by using feedback from validation, field service, post market surveillance, manufacturing indicators, corrective and preventative actions (CAPAs), etc., including maintaining the risk management SOP.
Provides input and guidance on the use of various statistical techniques and quality tools.
Provides Quality Engineering review/approval of Engineering Reports related to Design Controls.
Supports Validation and Verification (V&V) activities including writing, reviewing, and approving of plans and/or protocols/reports.
Oversees and/or works closely with impacted departments to ensure that any changes to the Design History File (DHF) are reviewed by subject matter experts including the QE and are captured appropriately within the QMS System.
Supports Reliability Engineering including the FDA's reliability of 99.999% (5-9s) for emergency use products.
Provides training on Design Controls and risk management to the team as needed.
Overseas medical device component incoming inspection program from a quality perspective providing quality engineering input where needed and executing quality assurance activities.
Reviews/ approves SOPs in the QMS, EHS, and other technical areas as the Quality representative.
Supports the implementation of continuous improvement activities to improve the QMS.

Education/ExperienceA Bachelor's degree with CQE experience or BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline is required.Three (3) to seven (7) years+ experience in a pharmaceutical or medical device environment is required with a portion of that directly involved in new product development or new product integration is preferred.An equivalent combination of education and experience may be substituted on a year to year basis. Certificates and LicensesASQ (American Society for Quality) certified or Certified Quality Engineer or equivalent is required. QualificationsThe requirements listed below are representative of the knowledge, skill, and/or ability required.

Ability to consistently promote, support, work, and act in a manner in support of the companys mission, vision and values.
Must have solid experience in Risk Management for medical devices ISO 14971
Strong ability for application and leading problem-solving, root cause analysis and related CAPA.
Must be able to interface well with others, especially Manufacturing Engineering, Research and Development (R&D) Engineering, and Regulatory.
Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
Ability to work independently, with excellent organizational, communication, leadership and problem-solving abilities.
Comprehensive knowledge of product development life cycle, risk assessment, and validation protocols.
Extensive knowledge of methods and process of medical device design controls.
Well-versed in the methodologies of V&V, and FDA (21CFR 803/806/820).
Sound knowledge of lab testing and machine shop equipment, drawings, ISO (ISO: 13485) regulations, Gage R&R, and advanced engineering concepts.
Well-versed in communicating effectively with knowledge of basic computer applications.
Experience with new medical device product development (combination product preferred but not required)
Proficient understanding of Medical Device QSR and ISO 13485

This job description doesn't constitute a contract of employment and Syncroness may exercise its employment-at-will rights at any time. Syncroness is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.PM20
PI150452248

Keywords: Syncroness, Broomfield , Quality Engineer, Engineering , Broomfield, Colorado

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