Job description

Join our team and produce products that save and enhance lives!
Shift Hours: Monday-Friday, First Shift; Full Time.

The primary purpose of this job is to lead the Validation Program for manufacturing equipment, processes and inspection equipment to ensure Quality System requirements are adhered to for medical device manufacturing in accordance with applicable Regulatory and Standards requirements for compliance.

We partner and innovate with our customers to provide the highest quality, life enhancing medical devices in the world.

New employees are eligible for the following benefits effective date of hire!

• Medical, dental, vision benefits, and much more
• Company-paid life insurance and disability benefits
• 401K with company match
• 17 days of paid time off (pro-rated) and 10 paid Holidays

Responsibilities:

• Adheres to Viant Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) Regulations, Company policies and operating procedures, and other regulatory requirements.
• Leads the Validation Program for the Viant Medical, Indianapolis Manufacturing Site in accordance with Regulatory requirements and Standards.
• Supports regulatory and agency inspections, audits, investigations, and inquiries regarding manufacturing equipment, processes and inspection equipment validations.
• Supports validation monitoring in accordance with the Validation Master Plan (VMP) and periodic review requirements.
• Leads and implements procedural updates as it relates to the validation program.
• Supports in the completion and maintenance of risk analysis.
• Leads the generation and completion of protocols and reports for equipment, process and test method validations.
• Interfaces with Manufacturing Engineers, Supply Chain and Operations to coordinate process validations and capability studies.
• Effectively communicates and interacts with customers.
• May lead or support the completion of capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
• May support the preparation of Quality Plans, including inspection, test and gauge requirements.
• Performs other functions as required.
• Operate with a high level of integrity and professionalism
• Committed to and accountable for achieving goals and objectives

Education:

• Bachelor’s Degree in Engineering or related field required or 7-10 years of experience working in a quality engineering or validation role within a regulated industry.

Experience:

• 5-7 years’ experience in medical device or regulated manufacturing

Skills/Competencies:

• Leadership in Quality Assurance principles in regulated industries
• Ability to multitask, lead, and drive initiatives to completion
• Competence in the selection and use of Quality Engineering and Validation Tools and Techniques.
• Strong communication skills and ability to align with key stakeholders
• Strong working knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. FDA 21CRF820, ISO 13485:2016; MDSAP; ISO14971, QSR, MDD, TGA etc.)
• Proficient in Microsoft Office and Minitab

Physical Requirements

• Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.
• Visual Acuity: Close vision.

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.

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