QUALITY MANAGER

Salary Range: $125,000 to $140,000

Location: This is an onsite position based at the Company's San Diego facility.

JOB PURPOSE

The Quality Manager leads Quality Operations and the Quality Management System (QMS) for the San Diego site, ensuring compliance with regulatory, customer, and business requirements. This role provides strategic and operational leadership for Quality Assurance and Quality Control, drives continuous improvement and risk management initiatives, and partners with site leadership to enhance product quality, operational performance, and customer satisfaction

PRINCIPAL ACCOUNTABILITIES

• Responsible for the Quality Management System (QMS) and Quality Operations, ensuring compliance with applicable regulatory, customer, and business requirements.
• Provide leadership, coaching, talent development, and performance management for Quality Assurance and Quality Control teams.
• Develop, implement, and maintain quality systems, procedures, controls, and metrics to ensure consistent product and process quality to meet customer expectations and quality standards.
• Establish quality objectives and KPIs aligned with business goals to drive compliance, operational excellence, and continuous improvement.
• Leads quality risk management for products, processes, suppliers, and quality systems across the product lifecycle.
• Ensures effective management of CAPA, nonconformances, deviations, complaints, adverse events, and change controls.
• Lead Management Reviews and provide executive leadership with updates on quality performance, compliance, risks, and improvement initiatives.
• Direct internal, supplier, customer, certification, and regulatory audit programs and ensure timely closure of findings and corrective actions.
• Ensures audit readiness and leads Quality representation during customer, certification, and regulatory inspections.
• Partner with cross-functional teams to integrate quality requirements throughout the product lifecycle and business processes.
• Establishes and maintains an effective supplier quality management program, including supplier qualification, monitoring, audits, performance reviews, and corrective actions.
• Promotes a prevention-based quality culture through employee training, risk management, process controls, data analysis, and continuous improvement initiatives.
• Provides leadership and direction to the Quality team through frontline supervision, ensuring effective execution of quality controls, compliance activities, and continuous improvement initiatives.
• Other duties as assigned.

SCOPE

The incumbent reports to the Quality Director and is responsible for the overall leadership and effectiveness of Quality Operations and the Quality Management System (QMS) for the San Diego site. The role works cross-functionally with Operations, Production, Engineering, Customer Service, Sales, and other business functions to ensure quality requirements are integrated into manufacturing processes and business operations. The incumbent serves as a key business partner, driving quality performance, regulatory compliance, continuous improvement, and customer satisfaction initiatives.

PERSON SPECIFICATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. The physical requirements and work environment described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE

Bachelor's degree in engineering, Manufacturing, Quality, or a related field.

Essential

5-7 years of experience in Engineering and/or Quality, preferably in a medical device industry.

Desirable

Minimum of 3 years of experience in a supervisory or management role.

Essential

Experience with quality risk management principles and methodologies within a regulated manufacturing environment.

Essential

Demonstrated success leading teams, driving change, and improving quality, compliance, and business performance through continuous improvement initiatives.

Desirable

Demonstrated expertise in manufacturing processes, quality systems, inspection methods, root cause analysis, nonconformance management, and CAPA processes within a regulated manufacturing environment.

Essential

Proficient in MS 365 applications

Essential

Experience utilizing ERP/MRP systems, electronic Quality Management Systems (eQMS), and data analytics and reporting tools to monitor quality performance, compliance, and continuous improvement initiatives.

Essential

Ability to work effectively in both office and manufacturing environments, including prolonged periods of sitting, standing, walking, computer use, visual inspection activities, occasional lifting of up to 25 pounds.

Essential

PERSONAL SKILLS AND KEY COMPETENCIES

Aligning Performance for Success: Focusing and guiding others in accomplishing work objectives.

Coaching and Developing Self and Others: Providing and welcoming feedback, instruction, and development guidance to help self and others excel in current or future job responsibilities; planning and supporting the development of individual skills and abilities.

Building Collaborative Relationships: Identifying opportunities and taking action to build strategic relationships between one's areas, teams, departments, units, or organizations including customers, to help achieve business goals.

Driving Execution: Translating strategic priorities into operations reality; aligning communication, accountabilities, resource capabilities, internal processes, and ongoing measurement systems to ensure that strategic priorities yield measurable and sustainable results.

Leading Teams: Using appropriate methods and interpersonal styles to develop, motivate, and guide the team to attain successful outcomes and business objective

Safety: Identifying and correcting conditions that affect employee safety; upholding safety standards.

Values

Innovation

We continuously push the boundaries of possibility through genuine collaboration and continuous improvement, striving for excellence

Integrity

We operate with honesty and transparency, staying true to our word.

Accountability

We hold ourselves responsible to superior standards in our work, delivering products that meet the highest levels of quality and precision in the industry.

Resiliency

We embrace challenges and adapt with agility, ensuring continuous improvement in every aspect of our work.

Empowerment

We fearlessly challenge the status quo, encouraging initiative from every team member to drive transformative ideas and solutions.

Community Impact

We take pride in knowing that our work improves lives