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Thermo Fisher Scientific · 1 day ago

Quality Engineering Manager

Santa Clara, CA

Full-time

Onsite

Senior Level, Lead/Staff

$112K/yr - $169K/yr

8+ years exp

Thermo Fisher Scientific is a leading company in the scientific industry, dedicated to making the world healthier, cleaner, and safer. The Quality Engineering Manager will lead and mentor a team of quality engineers, ensuring the development and execution of quality assurance strategies while fostering a culture of continuous improvement.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Manage and mentor a team of quality engineers and technicians, setting goals, providing guidance, driving ownership, accountability and fostering a culture of continuous improvement

Crafting personalized career development plans and performance reviews for each team member, finding opportunities, and defining individual goals to support these development plans

Ensure consistency with health and safety guidelines and legal obligations

Support in the development, execution, and upkeep of the site’s Quality Management System (QMS) and overall quality assurance strategy to align with organizational goals

Crafting new strategies to improve efficiency, elevate product quality, pinpoint process improvements, and adjust to the ever-changing business landscape while encouraging a culture of ongoing improvement and responsibility among team members

Understand customer needs and requirements to develop effective quality control processes that meet their needs

Oversee the quality deliverables for product development and incorporate manufacturability and quality standards into the design

Apply data analysis, Lean and Six Sigma methodologies, and deep-dive investigation to identify and address underlying issues to improve efficiency

Devise and review inspection specifications and plans for products or processes

Establish requirements for suppliers and monitor their consistency with these requirements

Be responsible for the Material Review Board (MRB) in reviewing, dispositioning and identifying corrective actions for non-conformance materials

Ensure products and processes align with applicable industry standards, regulations (e.g., ISO 9001 and ISO 13485), and customer specifications. This role requires supporting audits conducted both within the organization and by external parties

Collaborate with various departments, including engineering, manufacturing, product development, and supply chain, to ensure that quality standards are consistently upheld throughout

Support the investigation and resolution of blocking issues from customers and CAPA investigations

Qualification

Quality Management SystemLean ManufacturingSix SigmaISO 9001Root Cause AnalysisProject ManagementCommunication SkillsTechnical Team LeadershipAnalytical ThinkingMS Office ProficiencyAgile PLM ExperienceERP Systems KnowledgeProblem Solving

Required

Must be legally authorized to work in the United States without sponsorship

Must be able to pass a comprehensive background check, which includes a drug screening

Minimum Required Education: Bachelor's degree in a technical/scientific or related field

Minimum 8 years of proven experience working in an ISO9001 or ISO13845 manufacturing environment required

Minimum 5 years of managerial or supervisory experience required

Knowledge of quality management systems like ISO 9001, ISO 14971, and ISO 13485, process control, and the technical skills needed for the company's products

Demonstrated history of leading, guiding, and motivating a technical team, showcasing strong communication, interpersonal abilities, and capacity for addressing challenges

Extensive understanding of quality assurance methodologies, manufacturing procedures, root cause analysis, and corrective measures

Proficient in project management, budget oversight, and aligning quality goals with business objectives

Proficient in communication (both written and verbal), possessing leadership qualities, analytical thinking abilities, and adept at overcoming challenges when working with various teams and partners

Innovative thinking and problem-solving skills

Proven skill in communicating effectively to achieve excellent outcomes with both internal and external clients and collaborators

Motivated from within, excelling in a rapid team environment

Proficient in MS Office suites, SharePoint, Visio, Miro, etc

Ability to effectively adapt to fast-changing environments and apply the latest technologies such as artificial intelligence (AI) tools, database systems and mobile devices

Capability to operate within a traditional office setting and manufacturing environment

Must have the capability to lift and transport items weighing up to 45lbs, as needed

Required to be comfortable working at the computer for a full 8-hour period

Must be able to travel up to 10%

Preferred

ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is desired

Professional Certifications, such as Lean Manufacturing, Six Sigma (green or black belt), preferred

Experience with Agile PLM, Intuitive ERP or similar MRP systems

Benefits

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off (120 hours per year) + Designated Paid Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount