Quality Manager Jobs

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 employees 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 contributed to our employees’ skills and talents, that 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 to your future.

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

Professional Attributes

• Ensure efficient workflow of product inspections during all shifts.
• Well-developed teamwork and collaboration skills and ability to communicate clearly and effectively both verbally and in writing
• Compliant application of ISO 14971 and the associated risk management tools which includes hazard analysis, fault tree analysis, pFMEA
• Collaborate with the internal and external teams to ensure product safety, efficacy, and quality
• 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
• 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
• Develop and validate production processes and test methods with demonstrated documented capability
• Demonstrated application of root cause analysis tools to resolve problems in a timely manner when they arise
• Strong technical writing and reviewing skills
• Provide quality team members with feedback related to their performance and recommendations for improvements.
• Ensure all change control activities are performed in a compliant manner, especially those changes that require customer notification and/or approval prior to implementation
• Sound knowledge and demonstrated compliant application of the Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971
• Establish sampling plans based on sound statistical rationale and based on risk
• Ensure internal quality management system audits are planned, executed, and documented in accordance with the medical device regulations and the local quality management system
• Other duties as requested directed or assigned.
• Ability to build, manage, lead, train and develop the quality team and other local personnel as appropriate
• Maintain quarantine area and product disposition to prevent unintended use of nonconforming product
• Establish, monitor, and maintain the Quality Management System and apply continuous improvements as appropriate
• 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

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
• Knowledge of Federal, State, and Local environmental health and safety requirements
• Minimum 5 years in a leadership role in an injection molding environment preferred
• Experience in a manufacturing environment, possessing an understanding of general safety requirements
• Excellent computer skills using Excel, Access, Word, statistical software…
• Ability to lead and manage employees.
• ASQ “Certified Quality Manager,” “Certified Quality Auditor” preferred
• Thorough knowledge of plastic injection molding and assembly processes.
• Knowledge and application of ISO 14644/cleanroom competencies is a plus

What You’ll Love About Us:

• 401K, Plus Employer Match
• 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.
• Medical, Dental, Vision, Company Sponsored Life and AD&D, Short and Long Term Disability, Paid Parental Leave, and More…
• We understand how COVID has affected many businesses around the globe. Unfortunately, due to the pandemic, many companies had to permanently shut down and lay off workers. Because Westfall Technik is an essential business, we kept our doors open, our employees employed and kept our employees safe by following our COVID policy and procedures, which still stand in place today.
• Salary: (Based on education and experience)
• 11 Paid Holidays, Sick Pay, Vacation Pay