Syncroness Quality Engineer II in Westminster, Colorado
Quality Engineer II
Complex problems. Inspired solutions.
Job Title:Quality Engineer II
Syncroness 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.
We provide proven value and predictable results in demanding and regulated markets by employing our core competencies in:
Product and System Engineering
Core Engineering disciplines
NPD and Sustaining Engineering
Whatare welooking for?
The ideal candidate for this position has experience as a member of product development teams in the medical devices, aerospace, or other regulated industries. This candidate’s experience will include developing test plans and procedures and preparing certification-ready reports anddocument collections. Thiscandidate is detail-oriented, has a strong knowledge of development and/or production processes, and likes to see projects through to their finish, especially through the agency approvals process.
Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned.
Participate as project team member in support of Systems Engineers
Apply expertise in processes, standards, and tools to provide requirements interpretation and compliance design support to the product design teams and suppliers
Interpret relevant standards and apply risk management practices on projects in medical, aviation, and space industries
Consult with design engineers to provide guidance on aspects of regulatory and statutory requirements that affect the design and design decisions
Perform requirements validation analyses for products/requirements
Support product configuration management and documentation compliance
Review and edit content created by others to ensure that project documentation is ready for release and submission
Develop and lead the development of test plans and procedures and conduct validation and verification (V&V) testing of requirements, and support the acquisition of test equipment and data to support V&V activities
Develop and lead testing of production processes, including IQ/OQ/PQ
In coordination with Project Managers and Systems Engineers, the lead transition of designs from development into volume manufacturing
Plan and lead statistical process control efforts in production environments
Support teams in investigating root causes of failures in process or product and following nonconformities to complete resolution
Support teams in the presentation of objective evidence of conformity during external audits
Minimum of a Bachelor’s degree is required, scientific or engineering degree is preferred
Minimum of 5years related engineering experience is required
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Demonstrated experience working with and ability to interpret and regulatoryand qualification requirements, suchas IEC 60601, IEC 61010, 21 CFR 820, ISO13485, DO-254, DO-178, DO-160, ARP 4754, ISO 13485, ISO 14971, and AS9100
Demonstrated experience in guiding products through medical, aviation, and/or space industry qualification and certification
Knowledgeable of statistical processes is strongly preferred
Demonstrated experience in a procedure-controlled configuration management regimen
Solid understanding of the mechanical, software, and electrical engineering fundamentals applicable to regulated products
Demonstrated ability to establish proficiency in new regulatory areas
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
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.