Summary: Quality Engineering role working to bring to maintain and implement new elements of compliant medical device quality systems for the company’s innovative, first-to-market biomagnetic devices. Will take primary responsibility and lead for engaging and directing cross-functional colleagues to lead quality management of hardware and software design & development, supplier management, risk management, customer success, audit functions, process documentation, and provide regulatory and strategic planning support with continuous improvement in mind. Shall work to ensure company and product adherence to applicable medical device quality standards, including already MDSAP ISO 13485, ISO 14971, and forthcoming MDR.

Duties and Responsibilities include the following. Other duties may be assigned.

Lead and organize Document Control work to administer and maintain the company’s electronic quality management system, ensuring compliance to internal and external standards and timely routing and filing of quality documentation.
Support post-market quality tasks, including statutory reporting and complaint handling by working hand in hand with operations, regulatory, and commercial teams.
Maintain, follow, and optimize existing workflows for document management and progression, including but not limited to CAPAs, complaints, design reviews, audit reports, and risk files.
Work cross-functionally to support design controls and risk management activities compliant with ISO 14971 and 13485. Create risk management plans, perform product risk assessments, facilitate the failure mode effects analysis, and create a final risk management report. Maintain Design Controls Matrix for Software and Hardware elements of the device.
Provide support and product quality requirements to product development teams and commercial teams and verify via internal audit critical quality activities during the commercialization, manufacturing, design and development processes.
Assess technical standards against current Design History File, labeling and technical file requirements. Work closely with engineering and product teams in this effort. Assist in the creation and compliance of design and development documentation, Quality Records, and technical files for conformance to applicable requirements.
Maintain quality system architecture according to applicable standards. Responsible for revising and occasionally generating procedures, forms, and training related to the quality system.
Support review activities. Define and lead internal audits of quality systems. Assist in management review/presentation activities and assist in the creation of quality and regulatory strategy as related to ISO 13485. Assist in external audits for certifications.
Provide support for regulatory submissions and compliance efforts as it relates to all applicable medical device regulatory agencies, foreign and domestic (i.e. FDA, EU MDR, Notified bodies, etc.); as necessary.
Ongoing Qualification, and Maintenance of Supplier Files for a limited number of critical suppliers, including outsourced manufacturers.
Work adaptively in a fast-paced small team environment with aggressive deadlines, with occasional travel to offsite locations as required for training, audits, and site deployments

Education/Experience:

Bachelor level degree or above in Engineering (Mechanical or related)
7-10 years or more of experience in a degree-related quality assurance or development support role, ideally with both hardware and software .
Experience with design controls and documentation, test method development and validation, test execution, failure analysis and risk management; Preferably with both hardware and software.
Excellent Proficiency with quality systems and standards compliance (ISO 13485, FDA 21 CFR 820, ISO 14971, ANSI/IEC 62304 etc.)

Skills:

Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills
Project management and leadership skills, including the demonstrated ability to lead multi-departmental teams
High level proficiency with Microsoft Office
Quality Management Systems (preferably Electronic Quality Management Systems)

About Genetesis
Genetesis is a medical device company developing a biomagnetic imaging platform with a primary application in chest pain triage for cardiac ischemia. The imaging solution removes all the uncertainty, cost and lengthy waiting times associated with modern chest pain diagnostic tools physicians face in diagnosing and characterizing heart disease. The device provides an accurate, fast, radiation-free, and completely noninvasive method to determine the presence and location of coronary artery disease by recording, visualizing, and analyzing the heart’s naturally emitted magnetic fields.
http://genetesis.com

Reasoning and Language Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; outdoor weather conditions; risk of electrical shock; work with explosives and vibration. The noise level in the work environment is usually moderate.

Physical Demands:
The physical demands described here 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 30 pounds. Specific vision abilities required by this job include ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit; use hands and reach with hands and arms. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Quality Manager