Quality Engineer Medical Devices - QAPEL MEDICAL INC

About Q’Apel:

At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where Q’Apel comes in.

Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. Our startup philosophy requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Job Description Summary:

The Quality Engineer position is a hands-on key position with primary responsibility for all areas of Quality Engineering support of Q’Apel’s commercial products distributed in domestic and international markets.

This position also supports compliance with the US Quality Systems Regulations, ISO 13485, and the Medical Device Regulation (2017/745) including Q’Apel’s quality systems as defined in the company’s Quality Manual. Collects, analyzes, and presents quality metrics of overall fitness and effectiveness of Quality Systems to management as well as key metrics development, analysis, and report out to management.

Position Responsibilities and Authorities:

Quality Operations

• Responsible for all elements of Quality Engineering activities in support of Q’Apel’s commercial products distributed in domestic and international markets including the manufacturing, sterilization, inspection, and testing of products.
• Support engineering change control review and approval of production documentation and ensure supporting justification/ rationale is documented and provided.
• Support Nonconformance Control and CAPA activities. Assure NCMRs and CAPAs are identified and addressed in a timely manner according to procedure requirements.
• Support review of sterilization load documentation and assure compliance with validation requirements. Review lot history records for final product release per established procedure.
• Support supplier management implementation and maintenance activities. Assure suppliers are qualified based upon the risk level assigned and assure supplier monitoring activities are performed in a timely manner.
• Support equipment management implementation and monitoring activities (i.e., calibration, preventive maintenance, inspection, installation/ operation/ performance qualifications). Assure on-going monitoring is performed according to procedure requirements and that any issues or nonconformances are addressed in a timely manner.
• Assure management is notified and made aware of any concerns involving compliance and/ or product quality.

Quality Systems

• Champion a strong Quality culture at Q’Apel which includes creating and/ or enhancing systems to be highly effective and efficient and allow high compliance at all stages of the company growth and development.
• Maintain current knowledge of the quality system procedures and requirements, including domestic and international regulatory standards and regulations, and ensure compliance is adhered to and training documented.
• Assure audit readiness at all times. Support compliance audits from regulatory agencies, internal auditors, and suppliers.
• Assure training remains up to date. Coordinate and/ or provide training to company personnel for quality system procedures, annual Quality System Regulation/ ISO 13485/ MDR and other training as required.
• Support complaint handling and adverse event reporting activities including returned product investigations. Report findings within the complaint handling processes and in accordance with procedure requirements.
• Support CAPA activities including root cause analysis, correction, corrective/preventive action plan and verification of effectiveness of implemented actions for an effective CAPA system.
• Generate the Quality Review Report, a periodic report of quality system data from key support systems, and communicate results to management via Quality reporting including any concerns involving compliance and/ or product quality.
• Safety: Performs job functions in a safe and effective manner.

Qualification Requirements:

Education:

Experience & Skills:

• Experience and knowledge of FDA’s Quality System Regulations, ISO 13485, Medical Device Regulations (2017/745) and ISO 14971 Risk Management. Experience with Class III products is preferred.
• 4+ years Quality Engineering experience in the Medical Device industry with experience in catheter manufacturing, sterilization, and biocompatibility testing. Experience in a start-up environment is preferred.
• Strong ability to work effectively with all functions and at all levels both internal and external. Execution minded and biased to achieve goals and objectives in a timely basis.
• Strong analytical, problem-solving, and technical writing skills including the ability to independently author protocols and test reports. Ability to solve complex problems, including root cause identification, and implement efficient solutions or processes. Experience with process validations required for FDA and ISO compliance.
• Effective communication across all levels of the organization. Strong verbal and written communication skills.
• Works well under pressure, organized and self-motivated, independent contributor and strategic thinker and planner. Computer literacy and proficiency in Microsoft Office Suite is required.
• May be required to travel.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $100,000 to $130,000 + equity + benefits.