Overview
Manager, Quality Assurance I Jobs in Leonard, MI at Cooper Standard
Berkshire is the global contamination control leader for cleanroom and controlled environment consumable products. We provide customers with technically advanced materials aimed at application performance. We focus on total solutions that consistently minimize the risk of product and process contamination. With our customer relationships we continuously focus on complete engineered clean solutions. For over 55 years, Berkshire has understood and delivered world class manufacturing, reliable supply chain, highest standards for quality, technically advanced products assuring mutual success each step of the way.
The ideal candidate will be strategic-minded, be a team player that can also work independently with a positive attitude, be proactive, manage complex tasks and problem solve, and possess a high attention to detail. The Quality Manager must have the ability to collaborate with peers and management and demonstrate exceptional judgement and a high degree of professional maturity while modeling loyalty, integrity, and honesty.
This is an onsite position located in Whitsett, NC.
Key Job Functions
Assure continuous conformity with Berkshire supply, OEM, or customer facing specifications of product
Plan and conduct the activities concerned with the quality control and quality assurance of operational processes, materials, and products
Description of Candidate
Demonstrate integrity and professionalism
Demonstrate a positive attitude in the face of challenges
Maintain a professional demeanor both internally and externally with vendors, customers and suppliers
Maintain a high attention to detail to ensure compliance with standards
Self-motivator and excellent problem solver
Ability to work individually as well as positively and proactively in a team
Reacts with an appropriate sense of urgency to production and customer needs
Ability to communicate and work well with all levels of the organization
Qualifications of Candidate
Bachelor’s Degree from an accredited college or university in a business or science related field
Five + years’ experience in a quality management role
Solid understanding of sterility validation and guideline/processes, IQ/OQ/PQ and ISO compliance
Familiarity with FDA, cGMP, ANSI, AAMI
Excellent documentation, devising procedures, developing co-workers, ensuring compliance and follow through
Ability to effectively prepare and present information in on-on-one and small group situations
Ability to multitask, manage diversity, and facilitate effective problem resolution while maintaining a positive attitude
Ability to use judgement in the analysis of facts and circumstances surrounding individual problems and transactions and in the determination of action to be taken within the limits of standard or accepted practice
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to apply complex instructions that include conditionals to situations described in materials
Use of mathematics together with the use of drawings, specifications, charts, tables
Excellent computer aptitude and knowledge of Microsoft Office and ERP system software
Ability to use precision measuring instruments including equipment and personal computer to input data involving advanced skills knowledge
Job Description
Develop and initiate standards and methods for inspection and evaluation
Develop protocol for first run new products, NSQs for conformance to the specifications created during product design and aesthetics of finished product
Plan the analysis and inspection to assure the quality of the assigned product/process
Conduct onsite customer tours and lead audit
Review all relevant purchased products or components and provide input to the decision to accept the product and future purchases from the vendor; determine suitability for release to production
Document data obtained during all quality activities consistent with company policies and procedures; provide quarterly reports to Senior Management on issues, activities and progress of ongoing improvements
Develop new approaches to solve problems identified during quality activities and communicate recommended process improvements if warranted to Senior Management
Prepare and present technical and program information to team members and management
Prepare and act as Company representative for 3rd party audits
ISO internal auditor
Assist in customer complaint investigations; complete Corrective and Preventative Action Reports
Recommend improvements to training programs for personnel to achieve “Best in Practice” quality focused operations
Maintain working knowledge of government and industry quality codes and standards
Manage the sterility program for Berkshire products including Certificates of Sterility and Certificates of Irradiation using AAMI guidelines
Oversee integrated process for custom certificates that ship or are sent electronically with orders
Direct receiving, in-process and final goods inspection
Direct supervision of Quality Assurance Specialists and Administrators in NC
Evaluate and assist in hiring new quality department employees, review performances, handle disciplinary actions, cross training
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions
Job Expectations
It is expected that the employee will dedicate personal time to further his or her education as it relates to work at Berkshire. This should include time spent reading relevant trade publications, journals, and textbooks.
On average employment will require 40-50 hours per week
Strive to continuously build knowledge and skills and share expertise with others
Adherence to Berkshire’s Code of Conduct and Professional Ethics Standards
Desirable Skills / Experience
ASQ preferable
Textile industry (knitting, finishing, yarns), Knits and Non Wovens experience
Six Sigma working knowledge and experience
Root cause analysis experience
Previous experience with ISO 9001 system in manufacturing environment
Physical Requirements
Hands to finger, feel, and handle testing equipment and product; operate computer
Frequent standing, walking, sitting, reaching with hands and arms
Occasional lifting and moving of up to 25 lbs
Occasional climbing, balancing, stooping, crouching, crawling, smelling
Close, peripheral and depth perception vision
Moderate noise work environment
Occasional work in non-temperature controlled warehouse environment
Ability to gown per ISO Class 7, 4 and 6 environments as needed
Benefits:
Medical Insurance
Dental Insurance
Vision Insurance
Life and Voluntary Life Insurance
Short- and Long-Term Disability
Flexible Spending with Company Match
401(k) Retirement Savings Plan with Company Match
Paid Holidays
Paid Vacation
Personal/Sick
EAP Program
Tuition Reimbursement
These statements are intended to describe the general nature and level of work being performed by employees assigned to this job. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this job.
An Equal Opportunity Employer
www.berkshire.comShow more
Title: Manager, Quality Assurance I
Company: Cooper Standard
Location: Leonard, MI
