Viant Medical Laconia , NH 03246
Posted 3 weeks ago
New employees are eligible for the following benefits effective date of hire!
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
MAIN PURPOSE OF JOB:
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
Functional Execution
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)
Compliance
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
Specialization
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
POSITION REQUIREMENTS
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
Job Experience:
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
Skills/Competencies:
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
Physical Requirements:
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 is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
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
Apply Now
Viant Medical