Quality Engineer II
2 weeks ago
- Medical, dental, and vision benefits
- Company-paid life insurance and disability benefits
- Generous Paid time off and 10 paid Holidays
- 401k Plan with Company Match
- Tuition Reimbursement
Quality Assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Sr. Quality Engineer will be expected to provide support to Operations, interact with Customers and provide support for Engineering, Quality Systems and Process Engineering. This position will be integral in meeting the Quality Management System requirements. In requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Production Control, Supplier Management and other appropriate procedures for a variety of medical devices from concept through market introduction.
MAIN JOB RESPONSIBILITIES
Leadership
- Exhibits the Viant Medical Values (Teamwork, Customer Oriented, Be Agile, Integrity, Own It, Servant Leadership)
- Provide Quality Engineering direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner
- Lead implementation of continuous improvement projects or as subject matter expert for SPC, FMEA, and process validation
- Lead and provide Project Management support as needed
- Oversees (With Supervisor Input) Quality Engineering Technician Development and Training to support Value Stream
- Manage and Suggest Continuous Improvement project/strategies (Based on Site/Business Needs or Metrics) and report plans/updates during Project Governance and Site Management Reviews
- Maintain company compliance with FDA Quality Systems Regulations and ISO 13485 standards
- Actively participates (Often Leading) in external/internal audits, management review and other activities covered under Viant Medical Quality Manual, Policies and Procedures
- Compiles and writes training material and conducts training sessions on quality control activities
- Directs development maintenance of internal/external standards relative to Impact for Site
- Develop and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
- Devise sampling procedures, Measurement forms, and instructions for recording, evaluating and reporting quality and sustaining product data
- Performs measurement systems analysis to evaluate test and inspection equipment
- Leads disposition of discrepant material and devises process to assess product quality and investigate Root cause
- Leads Correction/Corrective Action assists in the resolution of complex problems (Where Applicable)
- Provide customer related quality and regulatory inquiries support
- Direct support for FDA and ISO inspections and registration
- Adheres to Viant Values and suitably represents Viant's best interests during Customer engagements and Audits
- Complies with all safety and quality requirements
- Supports Viant supply chain activities and assist with ensuring procedures are compliant to applicable sections of FDA quality system regulation and ISO 13485 regulation
- FDA quality system regulation and ISO 13485 regulations
- Technical (Individual Contributor)
- Lead Technical Contribution to Overall Risk Based Approval Process for supplier approvals and Process Qualifications. Inclusive of qualification of new/revised items, suppliers or manufacturing processes and controls
- Performs other functions as required or duties as assigned
Knowledge/Education:
- BS degree in engineering, a technical or scientific discipline; or with exception, CQE certifications / 5 plus years experience
- Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus
- 5-10 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility
- Experience with FDA and ISO 13485 Certification inspections is a plus
- 3 years plus Project management Experience, preference supervising diverse team
- Positive teamwork attitude
- Excellent internal and external customer service skills
- Good problem solving skills
- Understanding of Lean Manufacturing philosophies
- Strong written and verbal communication skills
- Ability to work well independently and with fellow team members
- Attention to detail and organization skills
- Computer skills with proficiency in Microsoft Outlook and Microsoft Office, Minitab preferred, Excel
- Excellent vision and hand-eye coordination
- Occasional periods of bending, lifting, and standing
- Occasionally required to lift up to 50 lbs
- Must be able and willing to wear personal protective equipment as required including:
- Protective eyewear
- Protective gowning (Safety Shoes covers, Apron, Hairnet, gloves)
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
Other details
- Pay Type Salary
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