Associate Director, Quality Engineering

At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. Heart disease kills more people than anything else in the western world, including all cancers combined. We're on a mission to be the world’s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical EKG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, hundreds of thousands of users have taken more than 100-million heart health measurements and counting.

AliveCor seeks am Associate Director, Quality Engineering to provide quality assurance and quality engineering support for AliveCor products ensuring that the actions result in meeting our customer needs while maintaining compliance.

This position will have direct influence on component, assembly, and final production release to market. This individual will manage a team of quality engineers and will actively participate in risk management, design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and associated documentation.

Responsibilities:

• Assist in the development, improvement, and management of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, nonconforming materials, product lot release testing, and finished goods control.
• Champion processes covering quality engineering and quality management to train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, and statistical methods.
• Create quality metrics which are communicated to the organization. This includes routine review of inspection data and preparation of statistical and operational performance reports
• Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO regulations and AliveCor SOPs.
• Drive the CAPA/Non-Conformance process as either a CAPA/Non-Conformance owner or contributor where required for sustaining products
• In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing. The employee has the responsibility and authority to report any instances to Quality and/or Regulatory and his respective management team
• Investigate product quality problems, determine root cause, gather and analyze data and implement corrective action to reduce or eliminate cause
• Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in accordance with ISO 13485 and 21CFR 820.
• Manage and perform lot release of finished product.  This includes confirming AliveCor products created by contract manufacturers meet all requirements for FDA and ISO compliance and AliveCor quality standards prescribed by AliveCor. This includes checking that QC testing of critical specifications, labeling of product that are compliant for both US and international products
• Leads customer complaint handling and investigation team, including assessment of reportability.  Supports regulatory compliance in regulatory reporting to health authorities
• Leads post market surveillance activities.
• Manage supplier controls by supporting compliance in performing supplier audits, performing supplier evaluations and managing supplier corrective action requests
• Ongoing duties include reporting on how well the QMS is working and where it is not, ensuring that the focus of the organization remains on the customer
• Oversees and manages the operational aspects of ongoing projects. Monitors the project from initiation through delivery. Reviews status of projects and budgets; manages schedules and prepares status reports. Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives
• Participate in designing and writing plans and protocols for testing of complex medical device products with the Quality and R&D team.
• Participate in internal audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.
• Partners with multiple external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Helps create qualification strategies to implement complex changes
• Provide authoritative guidance on ISO, QSR and external standards requirements to the new product development teams.
• Support the AliveCor Quality System
• Supports Regulatory Affairs in AliveCor regulatory submissions
• Work with Product Development, R&D (Hardware and Software Engineering), Manufacturing Engineering, Regulatory, Quality & Purchasing team to develop and execute Quality Engineering activities to meet commercial milestones 

• Bachelor’s to advanced degree in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience
• At least 8 years’ experience in quality engineering with medical device and/or other regulated industry, including 2 years recent supervisory experience developing direct reports
• Experienced in Quality System requirements such as Design Control, Risk Management, Quality, Production Process Controls, Supplier Controls, Corrective and Preventive Action, and Non-Conformance, Usability and Human Factors, Complaint Management and Post Market Surveillance.
• Demonstrated competency of industry standards (FDA QSRs, ISO 13485, MEDDEV, MDD, MDR etc.)
• Exceptional problem-solving skills; able to collect and process technical information, conduct root cause investigations, conduct robust risk assessments, etc.
• Demonstrated ability to communicate complex topics with a variety of audiences, including technical teams, management, auditors, and non-experts in a clear and effective manner
• Must have a positive attitude with excellent communication, negotiation, and interpersonal skills to maintain a team-oriented environment and develop critical relationships with contractor manufacturers and suppliers.

The Perks:

• Competitive salary and competitive stock options
• Generous vacation policy
• Maternity / Paternity Leave
• 401(k) matching
• Employee 100% covered for medical, dental and vision
• Mobile reimbursement
• Stocked kitchen weekly catered lunches
• A supportive, collaborative group of people who understand that success depends on the team

AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Principals only. Recruiters, please don't contact this job poster. Do not contact us with unsolicited services or offers.