Director of Quality (Medical Device) - Long Beach, California

Description

Hydrafacial is hiring a Director of Quality who will be responsible for the Quality team to focus on supporting, maintaining, and improving our ISO 13485-certified Quality Management System (QMS).

In this role, you will own or support several key QMS processes, such as internal audits, document management, or copy review.

Most importantly, you will work to incorporate quality assurance capabilities and methodology throughout the organization globally.

You will directly interact with many internal and external stakeholders, including Engineering, leadership, and regulators, to develop or maintain quality processes for our global and local medical device initiatives.

This position is 100% onsite in Long Beach, California.

HERE’S WHAT YOU’LL BE DOING :

Establish overall short and long-term quality strategy and objectives

Provide leadership and direction to the quality team to ensure adherence to quality standards and compliance with regulatory requirements to Iso 13485, 21 CFR 820, MDD / MDR, MDSAP, etc.

Collaborate with cross-functional teams to drive continuous improvement initiatives and address quality issues in a timely manner.

Drive cross-functional collaboration and engagement in creating, implementing, and driving QMS policies and procedures. Ensure training plans as required.

Develop strategic fit-for-purpose plans and policies to ensure seed product quality meets customers’ expectations.

Ensure a proactive quality culture so that customers receive the product to the highest quality and reliability standards;

study industry benchmarks and define the metrics required to assess performance. Report on Quality activities on a regular basis to the Senior Management team, ensuring accurate and timely reporting of the relevant Key Performance Indicators.

Work with suppliers and manufacturing to meet quality target goals, and drive issue resolution for quality problems.

Foster a culture of quality and promote awareness of regulatory requirements and best practices across all departments.

Own, support, and improve specific QMS processes and procedures. Examples include owning or supporting internal audits, document control or copy review

Develop and implement quality metrics and key performance indicators (KPIs) to monitor the effectiveness of the QMS and identify areas for improvement.

Lead and participate in various quality projects and initiatives, driving continuous improvement efforts within the organization.

Deliver updates to executive management on a regular basis.

Provide coaching and mentorship to quality staff, building and developing a high-performing team. Set clear performance expectations and objectives.

Implementing methods to inspect, test and evaluate products and production equipment

Ensuring that products adhere to quality standards

Tracking products through the manufacturing process to guarantee that each part of the process is correct

Support other Quality and Regulatory tasks, initiatives or MDRQ activities as required

HERE’S WHAT YOU’LL BRING TO THE ROLE :

At least 10 years of experience in a regulated industry such as medical device or pharma with a minimum of 5 of these years in a leadership position

Minimum of 5 years of experience in a manufacturing environment

Demonstrated understanding of FDA regulations, including 21 CFR Part 820, MDSAP, and relevant international standards, such as ISO 13485.

Expert understanding of Quality Management System principles and implementation methodologies.

Strong leadership skills, including coaching, team-building, training, and conflict resolution.

Proven ability to build and lead high-performing teams, fostering a collaborative and proactive work environment.

Excellent communication, interpersonal, and presentation skills.

Meticulous attention to detail and ability to manage multiple priorities effectively.

Strong organizational and strategic management skills

Strong analytical and problem-solving skills with a data-driven approach to quality improvement.

What else can you expect with Hydrafacial? PERKS! We proudly offer full health benefits, that’s medical, dental, vision, FSAs, HSAs, Accident Insurance, and even Pet Insurance for your furry family to name a few.

We also provide Basic Life / AD&D and Long-Term Disability coverage at no cost to you! Top these benefits off with an Employee Stock Purchase Plan and a 401(K) plan with an Employer Match.

Every person here is a key player in our success. We are firm believers in making the little things count each day so that the big things will follow.

If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.

We mean it when we say you’ll LOVE this role.

Pay Rate Range : $160,000 - $180,000)

An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs.

The range listed is just one component of BeautyHealth’s total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits.

Come grow and GLOW with us!

BeautyHealth is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws.

We are committed to working with and providing accommodation to applicants with physical and mental disabilities.

BeautyHealth does not accept unsolicited assistance or resumes / CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV / resume submitted by a search firm to any employee at our company without a valid written search agreement.

If we need additional support, we will be sure to reach out directly to one of our preferred providers.Please no phone calls or emails