Sr. Quality Engineer Long Beach, CA

WHY THIS ROLE MATTERS

SkinHealthSystems product quality begins with the quality of its suppliers and the rigor of its new product introduction process. The Senior Quality Engineer is the senior technical resource responsible for supplier quality management and New Product Introduction (NPI) quality engineering ensuring that every newcomponent material and product launch meets the clinical and regulatory quality standards that protect providers and patients. This role directly influences what gets built how it isvalidated and whether it reaches market at the standardSkinHealthSystems demands.

WHAT YOULL DO

• Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with Engineering to deliver quality parts materials and services that prevent defects and meet the highest reliability standards.

• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle from newly qualified parts through implementing strategies for driving product quality and continuous improvement.

• Collaborate with Engineering and Supply Chain to develop and deliver Product Acceptance Sampling Strategies Approved Supplier List coordination Supplier Owned Quality deployment and Control Plans for new products.

• Participate in risk management activities throughout the product lifecycle from development through manufacturing.

• Qualify suppliers according to company standards; ensure that suppliers deliver quality parts materials and services.

• Monitor parts from acquisition through the manufacturing cycle; communicate and resolve supplier-related problems as they arise.

• Develop and prioritize an auditing schedule to ensure designated suppliers are audited regularly against GMPandquality standards and contractualagreements.

• Evaluate suppliers internal functions to assess overall performance; provide feedback on their quality management practices.

• Trend and monitor supplier performance using statistical data including NCMRs Supplier Corrective Action Requests (SCARs) and scrap metrics.

• Ensure purchased products and components are manufactured and qualifiedin accordance withapplicable industry standards regulatory requirements and customer requirements.

• Perform other duties as assigned.

WHAT WERE LOOKING FOR

• Bachelors degree in Engineering Science ora technicalfieldor equivalent work experience.

• 5 years of experience in supplier and design control quality in the medical device industry.

• Expert knowledge of FDA 21 CFR Part 820 and ISO 13485:2016.

• PriorLeadAuditor or Auditor experience.

• Experience with Process Validations and/or Test Method Validations (IQ OQ PQ and/or TMV).

• Strong knowledge of supplier quality management techniques and best practices.

• Effective verbal and written communication skills withabilitytointerface withinternal stakeholders and suppliers.

Preferred

• ASQ Certified Quality Engineer (CQE) or Certified Supplier Quality Professional (CSQP).

• Prior experience with cosmetics consumables or pharmaceuticals.

• Experience with statistical process control and sampling methodologies (ANSI/ASQ Z1.4 Z1.9).

PHYSICAL REQUIREMENTS OF THE JOB

• Prolonged periods of sitting at a desk for up to 8 hours per day.

• Extended use of a computer keyboard and multiple monitors.

• Occasional travel to supplier sites manufacturing facilities and company events approximately 1525% annually.

• Must be able to lift and carry a laptop and inspection equipment weighing up to 25 lbs. during travel.

• Work Arrangement: Hybrid This position requires a combination of onsite and remote work in Long Beach CA.

We mean it when we say youll LOVE this role.

Base Pay: $95000 - $115000 Bonus

An employees 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 Hydrafacials total rewards package for our employees. Other rewards may include annual bonuses long-term incentives based on level paid time off and region-specific grow and GLOW with us!

What else can you expect with Hydrafacial
PERKS! Benefits include: Medical insurance dental insurance vision insurance FSAs HSAs accident insurance pet insurance company-paid life and AD&D insurance company-paid long-term and short-term disability insurance 401(k) with employer match paid time off (PTO) and paid holidays.

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