This Jobsfunter Listing is about Actalent in Boulder, CO 2022
About the job
- Description:* The Quality Engineer III is responsible for quality assurance throughout product lifecycle including but not limited to: process validation, equipment qualification, risk activities, and supplier qualification. This position may be required to act as the lead functional Quality representative on product development Core Teams. In that capacity, they must be a collaborative leader with assays, software algorithms, diagnostic test service for LDT and/or IVD experience in design practices, risk, and hazard management. They are accountable to ensure all documentation related to validation, supplier management, and other quality management activities, are structured and organized in accordance with document control procedures and design practices appropriate for the current business of Biodesix. The Quality Engineer III must have the judgment to prioritize activities based upon risk and resources available. While training and education at a large medical device manufacturer a plus, must have the ability to translate that experience into a smaller, earlier stage firm in a nimble, fast-moving environment with products subject to different regulations ranging from FDA to CAP/CLIA and NYS CLEP. The products developed by the Company are high complexity Laboratory Developed Test (LDT) diagnostic services and, to that end, experience with diagnostic test systems including assays, instrumentation and software and validation thereof according to CAP/CLIA, NYS CLEP, and various IVD guidance documents is critical. The role will communicate and coordinate with marketing, development, lab operations and Laboratory Directors to ensure appropriate documentation of test/process/equipment validation. JOB DESCRIPTION:
- Day-to-day management, development, and implementation of quality assurance programs by the Company.
- Deliver against Company goals to ensure core team projects are completed on time and meet the Company’s quality standards.
- Strong collaboration with operations, managers, research, and product development staff.
- Monitor production and purchasing services or activities to improve accuracy, customer service, or safety.
- Development of validation plans for equipment, software, and process.
- With Operations and Development leadership, examine existing procedures or opportunities for streamlining activities to meet product improvement needs.
- Contributor as the Quality function on verification & validation plans and reports.
- Leading the development of the risk management plan(s) for product realization.
- Assisting project teams on compliance with design requirements per CAP/CLIA, NYS CLEP and FDA QSR, European MOD, ISO l3485, ISO 14971, and other applicable ISO/EN standards as applicable to the Company.
- Accountable for the following key functions within the Quality team Product Development Process: o Design Control SOPs o Device Design History Files o Risk Management o Software Risk Management o Quality/Process Improvement and Validation o Supplier and Material Management o Lab Operation processes that impact quality COMPETENCY OR POSITION REQUIREMENTS:
- Knowledge and experience with (CAP/CLIA, NYS CLEP) LDT, QSR and PDP.
- Good working knowledge of object-oriented concepts and application design principles.
- Clear understanding and experience implementing ISO 14971:2019 Risk Management into a QMS.
- Working knowledge of developing equipment and/or process master validation plans.
- Must be a team player with strong customer orientation and ability to work within a diverse disciplinary cross-functional team environment.
- Ability to work with a small team and/or work as an individual contributor.
- Strong verbal, written, organizational, time management and interpersonal skills.
- Experience with creation and execution of testing planseviewing functional specification documents.
- Experience managing multiple supplier qualifications, reassessments, and correction actions.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Experience with testing automation solutions.
- Must be able to communicate effectively in a verbal and written format.
The successful candidate will be: o Able to perform all the required skills of this position with minimal direction.
- A motivated self-starter. o A detail oriented and quality minded individual with experience based good judgment. o Strong computer skills, including working knowledge of MS Office and e-mail
- Skills:* regulated environment, CAPA, equipment validation, design quality, CLIA, CAP, medical device, pharmaceutical industry, ISO13485, ISO14971
- Top Skills Details:* regulated environment, CAPA, equipment validation, design quality
- Additional Skills & Qualifications:*
- Bachelor of Science in Engineering or related discipline
- 4+ years of experience in Design Quality
- CAP/CLIA (College of American Pathologists / Clinical Laboratory Improvement Amendments)
- NYS CLEP (New York State Department of Health, Clinical Laboratory Evaluation Program)
- ISO 13485
- Experience Level:* Intermediate Level
- We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.*
- Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following: * *
- Medical, dental & vision * *
- 401(k)/Roth* *
- Insurance (Basic/Supplemental Life & AD&D) * *
- Short and long-term disability * *
- Health & Dependent Care Spending Accounts (HSA & DCFSA) * *
- Transportation benefits * *
- Employee Assistance Program * *
- Time Off/Leave (PTO, Vacation or Sick Leave)
- About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Vacancy Type: Full-time · Associate
Job Location: Boulder, CO
Application Deadline: N/A