Quality Systems Engineer at Weiss-Aug - East Hanover, NJ

Fairfield, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jul, 26

Salary

115000.0

Posted On

07 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ISO 13485, Quality control, Quality assurance, Internal auditing, Corrective actions, FMEA, Process flow charts, Inspection control plans, Blueprint interpretation, Geometric dimensioning and tolerancing (GD&T), Statistical analysis, Root cause investigations, Data collection software, ERP systems, Technical communication, Document control

Industry

Manufacturing

Description

Description Join Weiss-Aug – A Leader in Precision Manufacturing and Innovation Be part of a company that’s shaping the future of manufacturing where your ideas, skills, and passion matter. Weiss-Aug, is a leading provider of advanced manufacturing and engineering solutions with advanced facilities across the U.S. and Mexico for over 50 years. Why Join Us? At Weiss-Aug we are driven by a commitment to excellence, innovation, and continuous improvement. As a recognized leader in the industrial and commercial sectors, specializing in high-volume metal stamping, thermoplastic molding, and value-added assembly solutions our Weiss-Aug MedPharma serves the medical device and life science industry, offering unparalleled vertically integrated manufacturing solutions, partnered with in-house product design and engineering services. These combined capabilities provide Weiss-Aug a strategic advantage over the competition, being able to offer our customers a true, single-source supplier option, to meet their most challenging product innovation needs. As we continue to push the boundaries of what is possible, including our latest advancements in materials science, specialty coatings, laser processing, and hybrid additive manufacturing technologies – Weiss-Aug MedPharma needs the best minds in industry. Expanding our team is paramount, bringing in fresh perspectives, ideas and broad-based talent to further enhance our solution offerings, driving new growth and supporting our technology roadmap – including the release of finished drug-delivery / combination devices and machined implants. We're currently seeking a passionate and skilled Quality Systems Engineer to join our team and contribute to our mission of delivering high-quality, engineered solutions to our customers worldwide. In this role you will be responsible for the implementation of QC/QA procedures throughout the company such as developing, implementing and administrating the program, training and coaching employees and facilitating needed changes in the organization. Responsibilities Assists in implementing, establishing and maintaining the company quality system in accordance with ISO 13485 Medical and other specifications as required. Ensures the company meets any other additional customer specific requirements. Represents the company as the liaison with external parties regarding the company quality system and its’ capabilities. Is an Internal lead auditor and leads the Internal Audit program, coordinates and verifies corrective actions. Participates in supplier, customer and registrar audits Prepare various Company and Quality Department data reports measuring various quality and business performance indexes and management review report. Includes internal and customer corrective action databases. Maintain organizational knowledge by writing procedures and work instructions and administering the company’s document control system. Participate with Manufacturing Engineering and Tooling assisting in developing FMEA's, Process Flow Charts, and Inspection Control Plans. Assure that quality requirements are understood and attainable. Interpret blueprints and specifications related to geometric tolerancing, gauging, statistical requirements and related specifications. Interface with customers, sales and engineering to resolve quality issues. Assist in analyzing customer complaints and champion corrective actions. Maintain the company training program and assist training others on QMS processes. Support the troubleshooting of supplied material issues in manufacturing and facilitate Root Cause Investigations (RCIs) to assess the impact of supplied materials on final product performance. Develop suppliers through regular audits, quality meetings, and by monitoring improvement activities and corrective actions. Requirements Four-year college degree in engineering or a scientific discipline. 3-5 years’ experience in Quality Control/Assurance with an medical customer base. Requires verbal and written communication skills and the ability to communicate technical information to people of various degrees of ability. Must be organized and detail oriented. Needs a thorough understanding of automotive and medical industry quality requirements (FMEA, Process Flows, Control Plans, and system requirements). Proficient in blueprint interpretation, Geometric Dimensioning Tolerancing (GD&T), and statistic. Proficient in MS: Excel, Access Word, PowerPoint. Must have working knowledge or ability to learn as needed various types of software used in Data Collection Software, Statistical Software, and ERP Systems. This position is at our Fairfield, NJ location. Pay Range: $100,000 - $115,000 per year Other Benefits Include Medical, Dental and Vision 401 (k) with company match Holiday, Vacation and Sick Time Tuition Reimbursement Health Savings Accounts (HAS) Flexible Spending Accounts (FSA) Cigna Wellness Incentive Program Employee Assistance Program (EAP) Short Term Disability Group Life and Accidental Insurance Sun Life – Accident, Critical Illness, and Hospital Indemnity Insurance Smoking Cessation Program Pet Insurance US Pay Transparency The base salary for this role will be determined on a case-by-case basis and may vary based on the following considerations: job-related knowledge and skills, experience, and internal consistency. If your salary requirements exceed the advertised range and you remain interested in Weiss-Aug, we encourage you to apply. Weiss-Aug is an Equal Opportunity/Affirmative Action Employer. Applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other characteristics protected by applicable federal, state, or local law.

Responsibilities

The Quality Systems Engineer is responsible for implementing and maintaining quality procedures in accordance with ISO 13485 and other regulatory standards. They will lead internal audits, facilitate corrective actions, and collaborate with engineering teams to ensure product quality and compliance.