Quality Manager

Here at Westfall Technik, we pride ourselves on being the fastest growing Plastic Injection Manufacturing Company in the USA and soon Globally. While many companies outsource their work, we believe in keeping our jobs in the US. We currently support over 1,500 Team Members across 15 facilities in the US, and we are still growing.

At our Ansonia site, we invest in our people. Our overall success is largely attributed to our Team Members' skills and talents, which have been impactful and essential to the growth of our business. Here, you'll get the opportunity to test your knowledge and skills and become a critical player within Westfall. We want you to view your time at Westfall as an investment in your future.

We are currently seeking a Quality Manager with the following qualifications:

Professional Attributes

• Establish, monitor, and maintain the Quality Management System and apply continuous improvements as appropriate
• Collaborate with the internal and external teams to ensure product safety, efficacy, and quality
• Well-developed teamwork and collaboration skills and ability to communicate clearly and effectively both verbally and in writing
• Strong technical writing and reviewing skills
• Sound knowledge and demonstrated compliant application of the Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971
• Subject matter expertise and compliant development of production and process controls, risk management plans, product specific quality plans and control strategies along with the execution of these plans through clear and concise quality procedures and quality records established and maintained utilizing good documentation principles
• Compliant application of ISO 14971 and the associated risk management tools which includes hazard analysis, fault tree analysis, pFMEA
• Ensure all commitments and obligations defined in customer quality agreements are understood and consistently met by those individuals and functions at the sites that perform work defined within these binding agreements
• Ensure all change control activities are performed in a compliant manner, especially those changes that require customer notification and/or approval prior to implementation
• Establish sampling plans based on sound statistical rationale and based on risk
• Develop and validate production processes and test methods with demonstrated documented capability
• Ensure first article reports on all new molds are completed per local requirements and in accordance with customer expectations which includes full dimensional evaluations as required
• Demonstrated application of root cause analysis tools to resolve problems in a timely manner when they arise
• Ability to build, manage, lead, train and develop the quality team and other local personnel as appropriate
• Ensure internal quality management system audits are planned, executed, and documented in accordance with the medical device regulations and the local quality management system
• Ensure efficient workflow of product inspections during all shifts.
• Provide quality team members with feedback related to their performance and recommendations for improvements.
• Maintain quarantine area and product disposition to prevent unintended use of nonconforming product
• Other duties as requested directed or assigned.

Desired Skills and Experience

• Bachelor's degree in Engineering, Quality, or Science related field; plus, minimum, 7 years of experience in a quality discipline. A minimum of 5 of those years should have been in a managerial/decision-making capacity
• Thorough knowledge of plastic injection molding and assembly processes.
• Minimum 5 years in a leadership role in an injection molding environment preferred
• ASQ "Certified Quality Manager," "Certified Quality Auditor" preferred
• Knowledge and application of ISO 14644/cleanroom competencies is a plus
• Knowledge of Federal, State, and Local environmental health and safety requirements
• excellent computer skills using Excel, Access, Word, statistical software...

What You'll Love About Us:

• Salary: $125K-$145K D.O.E
• 11 Paid Holidays, Sick Pay, Vacation Pay
• 401K, Plus Employer Match
• Medical, Dental, Vision, Company Sponsored Life and AD&D, Short and Long Term Disability, Paid Parental Leave, and More...
• We are committed to creating a diverse work environment and proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, region, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other basis protected by law.