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HepQuant is seeking a dedicated and motivated individual to be responsible for providing quality assurance and engineering support for clinical and commercial In-Vitro Diagnostics; maintaining, and improving the Quality Management System (QMS) process and methods; and ensuring alignment with all applicable FDA, CLSI, European MDR, IVD-R, and ISO requirements i.e., 21 CFR parts 4; 820; 210; 211, IEC 62304, ISO13485/ 14971/ 13408, etc., while utilizing metrics to continually improve quality processes and efficiency. This position will report to the Director of Quality & Engineering.
Responsibilities
- Ensure adherence to internal standards and compliance with formal external quality standards, such as ISO 14971 & ISO 13485.
- Identify and document potential nonconformities and perform root cause analysis for quality failures to implement corrective actions.
- Collaborates with cross-functional teams to identify and mitigate quality risks.
- Adherence to change management while providing revisions and updates to quality procedures & standardized work instructions.
- Initiate supplier qualification activities and evaluate supplier performance.
- Conduct audits of production processes and ensure compliance with regulatory standards.
- Assist with design development and transfer to manufacturing, including quality control activities from production processes to the shipment of final product.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Review and approve product device history records.
Qualifications
- Bachelor’s degree in an engineering discipline (Chemical, Mechanical, Biomedical, etc.) and 0-2 years in medical device, pharmaceutical, or biomedical, manufacturing experience or
- 2-4 years in a technical role in medical device, pharmaceutical, or biomedical manufacturing; with industry specific certification. i.e. ASQ CQE, SSGB, IVDR Compliance expert.
Required Skills
- Strong problem-solving and analytical ability and demonstrated ability for critical thinking, problem solving and innovation.
- Advanced experience with Microsoft Office Suite and Grand Avenue Software.
- Proficiency with statistical software such as MATLAB, Minitab, etc.
Preferred Skills
- Commitment to HepQuant Vision and Values.
- Hands-on work: ability to compile own reports, studies, data.
- Detail oriented, able to work individually, while also proving their ability to work collaboratively with colleagues, and teammates to create a results-driven, team-oriented environment.
- Demonstrates a strong professional work ethic, while striving to meet personal and organization performance goals.
- Excellent written, verbal, and interpersonal communication skills with an acute ability to listen attentively and to communicate effectively throughout all levels of the organization.
- Professional demeanor and ability to interact with persuasiveness and confidence.
- Ability to function as a strong member of a highly motivated and integrated team.
Pay range and compensation package
Disclosure as required by Colorado law, the annual salary range for this position is $60,000 - $80,000. The actual compensation may vary based on work experience, education and skill level. The salary range is HepQuant’s good faith belief at the time of this posting.
Equal Opportunity Statement
HepQuant is committed to diversity and inclusivity in the workplace.
Work Environment & Physical Demands
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must occasionally lift and/or move up to 25 pounds (lifting boxes, files, etc.) Specific vision abilities required by this job include close vision, color differentiation, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is required to sit, stand, walk, talk and hear.
Classification: Salaried, Exempt
Status: Full-Time
Location: Denver, CO - On Site Required
Travel: Position may require up to 10% travel via airplane, car, and overnight stays.
About HepQuant LLC
HepQuant develops non-invasive, quantitative tests that measure liver health. The HepQuant DuO Test enables healthcare providers to manage patients with liver diseases more effectively. The HepQuant DuO Test delivers information about liver cell function and portal-systemic shunting, attributes of liver disease that are associated with clinical outcomes. Results may be used by a physician in conjunction with clinical evaluation and other tests to aid in the decision to proceed with or defer invasive procedures, to monitor treatment response, or to predict disease progression and adverse outcomes, such as ascites, encephalopathy and variceal bleeding.