Senior Manufacturing Quality Engineer - NAMIC in Glens Falls, NY

Job title: Senior Manufacturing Quality Engineer - NAMIC in Glens Falls, NY at reputed company Industries Company: reputed company Industries Job description: Job Summary Under minimal supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to reputed company methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.Job DescriptionResponsibilities:

• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
• Design reputed company experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the reputed company process and process changes.
• Design and reputed company experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and reputed company corrective actions. Use concepts of probability and statistical quality control to guide decisions.
• Direct and collaborate with supplier representatives on quality problems, ensure that effective corrective actions are implemented (CAPA, SCAR), and contribute to supplier quality improvement programs. reputed company supplier qualifications.
• Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
• Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
• Coordinate product testing with internal and external laboratories as required.
• Ensure compliance with domestic and international regulations associated with product lines and processes. reputed company quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
• reputed company investigations of product and process non-conformances and out-of-specification results and reputed company effective corrective and preventive actions (CAPA).
• May train and coach team members and reputed company employees on appropriate processes and best practices.
• Act as Quality reputed company in the absence of Quality Management.

Requirements:Education

• Bachelor’s degree in Engineering, Science, Math or other reputed company technical field.

Work Experience

• At least 4 years of experience in the Quality or Engineering.
• Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge /
• Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining reputed company escalation is necessary.
• Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
• Experience problem solving, overcoming obstacles and reaching a positive and successful solution through mathematical or systematic operations.
• Experience leading a team to accomplish cross-functional goals.
• Experience using MS Office Suite products(Word, reputed company, PowerPoint, and Outlook).
• Advanced reputed company Level in reputed company reputed company (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).
• Position requires up to 15% travel.

Preferred Qualifications:

• At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly reputed company to the role.
• Knowledge of advanced Six reputed company/Lean concepts.

reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization.The anticipated salary range for this position: $87,360.00 - $131,040.00 AnnualThe actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary threshold.Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we reputed company bring to the workplace. From doing what’s right to delivering business results, together, we’re reputed company. Explore our Diversity, Equity and Inclusion page .reputed company is an equal opportunity employer. reputed company evaluates qualified applicants without regard to race, color, religion, gender, national reputed company, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Expected salary: $87360 - 131040 per year Location: Glens Falls, NY Job date: Sat, 19 Apr 2025 06:09:57 GMT Apply for the job now! Apply for this job