Title:          Quality Engineer

Reporting to:   Director of Quality

Location:      New Hampshire, USA 

We have an exciting opportunity for an enthusiastic, results-driven and performance-driven Quality Engineer to join our growing team!  Reporting to the Director of Quality, the Quality Engineer will be remote and will be responsible for The Quality Engineer supports the Quality Management System and provides quality engineering support across product development, manufacturing, supplier management, and post-market activities. This role partners closely with Engineering, Operations, Regulatory Affairs, and suppliers to investigate issues, assess changes, support corrective actions, maintain quality system processes, and help ensure compliance with applicable regulatory and quality requirements.

The position serves as a key technical quality resource within the organization and plays an important role in driving issues to resolution, supporting continuous improvement activities, and maintaining the effectiveness of the Quality Management System.

Responsibilities 

• Investigate product, supplier, manufacturing, and quality system issues and support resolution activities.

• Support CAPA activities, including investigation, root cause analysis, action planning, implementation, effectiveness verification, and follow-up.

• Review and assess design, material, supplier, process, and documentation changes for potential quality and regulatory impact.

• Support risk management activities, including maintenance of risk management files and assessment of changes that may impact product risk.

• Work with Engineering, Operations, and suppliers to identify compliant and practical solutions to quality-related issues.

• Support supplier quality activities, including issue investigation, supplier corrective actions, change assessments, and supplier communications.

• Participate in internal audits and support external audits and regulatory inspections.

• Support maintenance of the Quality Management System, including document control, training, quality metrics, audit readiness, and continuous improvement initiatives.

• Review quality records, change orders, engineering documentation, and other quality system records for completeness and compliance.

• Track quality actions and help ensure commitments are completed, documented, and sustained.

• Serve as a quality resource to Engineering and other functional groups by providing guidance on quality system requirements, risk management, change control, investigations, and corrective actions.

• Support onboarding of new suppliers and contract manufacturers as required.

• Identify opportunities to improve quality system processes and overall operational effectiveness.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field.

• Minimum 5-8 years of experience in Quality Engineering, Quality Assurance, or Quality Systems within the medical device industry.

• Working knowledge of FDA Quality System Regulation, ISO 13485, risk management principles, and medical device quality system requirements.

• Experience supporting investigations, CAPAs, supplier quality activities, and change management processes.

• Experience working cross-functionally with Engineering, Manufacturing, and Regulatory Affairs teams.

• Strong technical problem-solving, communication, and organizational skills.

• Ability to manage multiple projects and priorities in a fast-paced environment.

• Excellent communication and interpersonal skills.

• Language proficiency required; English 

• Professional experience and proficiency required with Microsoft Office 

Preferred Qualifications

• Experience supporting contract manufacturers and supplier quality programs.

• Experience participating in regulatory inspections and certification audits.

• ASQ Quality Engineer certification or equivalent quality certification.

• Experience with electronic Quality Management Systems and PLM systems (Arena preferred)

Compensation

• Base salary range: $80,000-$100,000

• Benefits: Comprehensive package starting on Day 1, covering medical, dental, vision, life insurance, and a 401(k) match, among other benefits.

What you will be part of – our Venus Culture

Venus believes in pushing boundaries while embracing creativity and innovation. Our employees are a critical part of our company’s performance and are at the core of its success. At Venus, we rely on our employees, customers, and network of industry professionals around the world to continuously improve and Deliver the Promise. In order to do that, we ensure that everyone operates with the same values and vision.  At Venus, we promise to give you Endless Opportunities, allow you to Foster Innovation and be part of Delivering a Best-In-Class Offering.

Venus is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. Venus is committed to accommodating persons with disabilities. Accommodation is available on request for qualified candidates during each stage of the recruitment process. We may use artificial intelligence (Al) tools to support parts of the hiring process.