10 days old

Sr. Quality Engineer

Kelly Services
Boulder, CO 80305
The Sr. Quality Engineer (QE) position will, under limited supervision, perform complex quality work of a broad nature. The Sr. QE will apply knowledge of applicable regulations, standards, principles, theories, and concepts to ensure compliance of quality system procedures and processes. This position will support QMS SOP development for effective, efficient compliance and in support of high-quality product. This position reports to the Quality Assurance Manager.

Assignment to and ownership of several of the following areas:

+ **QMS** support on-going efforts to implement and maintain SOPs for compliance to ISO 13485:2016 and other applicable standards and regulation.

+ **Risk Management** host risk management sessions, such as hazard analyses or FMEAs.

Ensure risk management efforts are occurring to plan and compliant with ISO 14971:2019.

+ **Software Tool Validation** draft software requirements, protocols, and reports for software tools used in manufacturing processes.

+ **Internal Audits** support Internal Audit program by performing, reviewing and addressing audit results, as appropriate.

+ **Design and Development** ensure quality objectives and deliverables are achieved during design and development efforts.

+ **Supplier Controls** conduct supplier audits, assess supplier performance.

+ **CAPA ** issue Corrective Action / Preventive Action (CAPA) for systemic issues, complaints, etc.

Drive root cause investigations and completion according to target implementation date and without undue delay.

+ **NCMR** issue Non-Conforming Material Reports (NCMRs) for out of specification parts, subassemblies, and assemblies. Support and monitor timely disposition of materials.

+ **Document and Record Control** work with engineering and production teams to develop DMR, DHF, and DHR documentation.

+ **Management Review** Supply data for Management Review meetings and other KPI assessments as requested.

+ **Test Method Development and Inspections** use knowledge of inspection methodologies to design and perform incoming, in-process, and final inspections.

+ **Production Controls** work with production team to implement and maintain production controls.

+ **Process Validation** review process validation protocols, participate in execution of protocols, and report on results.

+ **Equipment PM and Cal ** work with other QA team members to ensure equipment program is compliant.

+ **Training and Competence** provide training on QMS topics, ensure training programs are occurring as planned provide mentoring to junior Quality team members.

+ **Post Market Surveillance** participate in Post Market Surveillance planning and execution.

+ Proven working experience

+ As a quality engineer, preferably within the IVD or medical device industry

+ Working knowledge of ISO 13485:2016 standard

+ Working knowledge of FDA, Canadian, and EU IVD regulations

+ Experience related to the above listed Job Duty categories

+ Proficient and experienced in spreadsheets, MS Office, statistical software, and other QMS software applications

+ Outstanding technical writing and communication skills

+ A collaborative approach to internal and external customers

+ The ability to work both independently and within the QA team

+ Skilled at building relationships with cross-functional teams

**Education and Experience:**

+ Bachelors Degree in engineering, science, or other related technical field

+ 7-10 years of quality assurance experience, a significant portion of which has been in IVD or medical device industry

+ Or equivalent combination of education and experience

+ Recognized quality certification (e.g., CQE) preferred, but not essential

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-09 Expires: 2022-06-09

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Sr. Quality Engineer

Kelly Services
Boulder, CO 80305

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