Director Medical Device QMS

Needham, MA - USA

Monthly Salary: $ 190530 - 232870

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

About Us

SharkNinja is a global product design and technology company with a diversified portfolio of 5-star rated lifestyle solutions that positively impact peoples lives in homes around the world. the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories driving significant growth and market share gains. Headquartered in Needham Massachusetts with more than 3600 associates the companys products are sold at key retailers online and offline and through distributors around the world.

The Director of Medical Device QMS for New Product Design will lead the quality management initiatives for the development of new medical devicesand ensure complianceofproductinmarket. This strategic role is crucial for ensuring that all new products are designed and developed in compliance with regulatory standards promoting a culture of quality throughout the product lifecycle and ensuringweare executing to our QMS policy and procedures.

Key Responsibilities:

QMS Strategy Development:Develop and implement the Quality Management System (QMS)for ourmedical device portfolio ensuring alignment with regulatory requirements (e.g. FDA ISO 13485).

Cross-Functional Leadership:Collaborate with R&D engineering marketing and production teams to integrate quality principles into the new product design processand legacy product maintenance toensurequality is embedded from the outset.

Regulatory Compliance Oversight:Ensure that all new medical devices meet applicable regulatory standards throughout the design and development phases including managing submissions and audits.

Risk Management:Lead risk management activities during the product design phase conducting thoroughassessmentsand ensuringappropriate mitigationstrategies are in place.

Training and Development:Establishtraining programs to promote quality awareness and best practices related to new product development among cross-functional teams.

Quality Metrics and Reporting:Define and track quality metrics related to new product design preparing regular reports for senior management that highlight compliance status risks and opportunities for improvement.

Continuous Improvement:Drive initiatives to enhance the QMS processes related to new product designleveragingfeedback and data analysis to implement best practices.

Stakeholder Communication:Act as the primary point of contact for quality-related inquiries concerning new product design ensuring clear communication with internal and external stakeholders.

Qualifications:

Bachelors degree in Engineering Quality Assurance Life Sciences or a related field; advanced degree preferred.

Minimum of 10 years of experience in quality management within the medical device or regulated consumer goods industries with a focus on new product development.

Deep understanding of regulatory requirements (FDA ISO 13485) and quality management systems.

Proventrack recordof successfully leading quality initiatives in a product development context.

Strong leadership and interpersonal skills with the ability to influence and engage cross-functional teams effectively.

Excellent analytical and problem-solving skills with a commitment to data-driven decision-making.

Strong communicationskills capable of conveying complex information to diverse audiences.

Salary and Other Compensation: The annual salary range for this position is displayed below. Factors which may affect starting pay within this range may include geography/market skills education experience and other qualifications of the successful candidate.

The Company offers the following benefits for this position subject to applicable eligibility requirements: medical insurance dental insurance vision insurance flexible spending accounts health savings accounts (HSA) with company contribution 401(k) retirement plan with matching employee stock purchase program life insurance AD&D short-term disability insurance long-term disability insurance generous paid time off company holidays parental leave identity theft protection pet insurance pre-paid legal insurance back-up child and eldercare days product discounts referral bonus program and more.

This posting will close within 90 days from the original posting date.

Pay Range

$190530 - $232870 USD

Our Culture

At SharkNinja we dont just raise the barwe push past it every single day. Our Outrageously Extraordinary mindset drives us to tackle the impossible push boundaries and deliver results that others only dream of. If you thrive on breaking out of your swim lane youll be right at home.

What We Offer

We offer competitive health insurance retirement plans paid time off employee stock purchase options wellness programs SharkNinja product discounts and more.We empower your personal and professional growth with high impact Learning Programs featuring bold voices redefining whats possible. When you join youre not just part of a companyyoure part of an outrageously extraordinary community. Together we wont just launch productswell disrupt entire markets.

At SharkNinja Diversity Equity and Inclusion are vital to our global success. Valuing each unique voice and blending all of our diverse skills strengthens SharkNinjas innovation every day. We support ALL associates in bringing their authentic selves to work making an impact and having the opportunity for career acceleration. With help from our leadership associates and our community we aim to have equity be a key component of the SharkNinja DNA.

Learn more about us:
Life At SharkNinja
Outrageously Extraordinary

SharkNinja Candidate Privacy Notice

For candidates based in all regions please refer to this Candidate Privacy Notice.
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We do not discriminate on the basis of race religion color national origin sex gender gender expression sexual orientation age marital status veteran status disability or any other class protected by legislation and local law. SharkNinja will consider reasonable accommodations consistent with legislation and local law. If you require a reasonable accommodation to participate in the job application or interview process please contact SharkNinja People & Culture at

Required Experience:

Director

About UsSharkNinja is a global product design and technology company with a diversified portfolio of 5-star rated lifestyle solutions that positively impact peoples lives in homes around the world. the company has a proven track record of bringing disruptive innovation to market and developing one ...