Overview
Quality Assurance Manager-Pharma Jobs in Hope, NJ at Biolink360
Under the direction of the Quality Manager, the Quality Engineer is responsible for internal, supplier, and customer quality activities.
TLX Technologies is a highly technical, globally minded engineering organization that focuses on solving application challenges and offering excellent solutions to our customers. We provide custom electromechanical solutions to customers in a variety of industries – automotive, off-highway, motorsports, & fire protection. While working with customers with many diverse applications, TLX Technologies focuses on industries that are forward-thinking and innovative.
OUR BENEFITS
All full-time employees are eligible for company sponsored benefits after completing the probationary period.
Health, dental, and vision insurance
401k with generous company match
Company paid Disability Insurance and Term Life coverage
Paid Holidays and Time off
Paid Funeral, Jury Duty and Parental Leave
Tuition Reimbursement
Adoption Assistance
OUR CULTURE
TLX Technologies purposefully hires people with diverse backgrounds and skill sets to form a cohesive team working together to deliver the best solutions for our customers. Honesty, openness, and respect towards each other provides a culture where employees can learn and grow.
We Make Time for Fun
A variety of company-sponsored events and downtime are scheduled throughout the year to give employees a chance to unwind and connect. We strongly believe that a proper work/life balance is essential to a healthy work environment.
We Recognize and Reward
TLX employees are recognized for their hard work and contributions. Employees are encouraged to take ownership of their ideas – from design and process improvements to individual goals and community outreach.
We Engage the Next Generation
We love opening our doors for school tours, college interns, and scholarship recipients. Interns expand their skills while tackling meaningful projects alongside our skilled employees. TLX also funds scholarships to encourage students pursuing careers in engineering or manufacturing.
We Support Our Community
TLX actively supports the community that we work in. Through employee participation, item donation drives and financial contributions, TLX is able to give back to employee nominated charitable organizations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
All employees at TLX work to satisfy the customer. Each department has expected core responsibilities, but these responsibilities do not define us. Rather, they simply provide a starting point where we work to satisfy the customer, continuously improve ourselves, others and the organization.
Quality Engineer
Reviews and processes supplier PPAPs; creates and submits customer PPAPs
Participates in Supplier Audits, and works with supplier for problem resolution
Participates in both internal and external corrective actions, including working with external parties in investigation, disposition, and resolution.
Provides quality assurance support for production and inspection operations
Works cross functionally to resolve quality issues related to assigned products and/or processes
Understands and updates Process Flow Diagrams, Potential Failure Mode and Effects Analysis and Process Control Plans
Understands Six Sigma principles, identify and participates in activities
Champions the Gage R&R and Equipment Verification process (internal calibration)
Completes CpK analysis
Clear understanding and participation in Root Cause analysis activities, FMEA’s, Flows, Control Plans, and other Quality activities.
Identifies design constraints and works with internal and external resources to resolve the constraints
Supports new product launches, scale up, and continuous improvements through production lines installation and qualification
Review and process supplier PPAPs (existing product)
Identifies and leads 1-2 continuous improvement initiatives per year
Creates and maintain cell dashboards and quality reporting, and suggests areas for improvement
Investigate and contain concerns which includes inspecting, testing and possibly sorting material.
Behavioral:
Must have potential to advance to Sr. Quality Engineer
Proactive on tasks (looking for solutions and not waiting, constantly pushing forward)
Responsible (demonstrate that others can trust you)
Demonstrates that he/she can be part of a solution (both technical and behaviorally)
Good verbal and written skills, in both a technical and non-technical environment
Demonstrated Competence:
Understands ISO 9000 and IATF 16949
Ability to support customer and supplier meetings and work directly with customers and suppliers on quality related tasks.
Understands and utilizes all applicable TLX process and procedures.
Understands audit documents
Good mechanical aptitude, and working knowledge of different materials (metals, plastics, etc), as well as coatings/finishes and hardware.
Good working knowledge of different manufacturing process capabilities; CNC, injection molding, welding, milling, etc.
Ability to support customer meetings and work directly with customers
Ability to manage suppliers as they relate to
Able to design product(s) with input from others on lessons learned / best practices.
Understands basics of Cost of Goods (COGS)
Education and/or Experience:
Bachelor’s Degree (BS) from an accredited college or university in an Engineering related field or acceptable type & amount of work experience in a quality related role
Firm understanding of ISO 9000 and IATF 16949 and operates under said system
Basic working knowledge of Microsoft Suite of products with a strong working knowledge of Excel
Good working knowledge of manufacturing equipment
Product manufacturing, inspection and testing experience
Six Sigma Green Belt preferred
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Parental leave
Referral program
Retirement plan
Tuition reimbursement
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Work Location: In person
Title: Quality Assurance Manager-Pharma
Company: Biolink360
Location: Hope, NJ
