BellevilleRecruiter Since 2001
the smart solution for Belleville jobs

Quality Manager

Company: Permobil
Location: Belleville
Posted on: November 25, 2022

Job Description:

*Provides leadership for Permobil Seating and Positioning locations and functions in areas of regulatory compliance, quality assurance, and quality control by leading department, establishing standards, solving quality issues, determining global regulatory requirements, documenting and reporting quality results, acting as Company's main contact with regulatory authorities, and acting as a primary customer liaison for quality issues. Ensures company compliance with applicable quality standards and regulatory r**equirements necessary to register, distribute, and sell products including ISO 13485, FDA QSR; and EU regulations.*
OVERSEES PRODUCT QUALITY AND RELIABILITY BY:
Implementing company quality standards for products and manufacturing processes; establishing company goals related to quality; ensuring conformance with product specifications; evaluating the disposition of non-conforming material; utilizing statistical analysis and making appropriate specification changes when necessary; determining need for corrective action for product nonconformance, product performance, or customer feedback; enforcing quality assurance policies and procedures and government requirements; establishing best practices and systems to be used to improve outcomes.

LEADS REGULATORY COMPLIANCE EFFORTS BY:
Developing, implementing, and overseeing compliance strategies and policies necessary to register, distribute, and sell company products within specified markets relative to production, distribution, record keeping, etc. of Company's products; establishing and maintaining formal lines of communication with all departments and executive staff as it pertains to regulatory concerns; acting as main contact with regulatory bodies (e.g. FDA) and authorized representatives; ensuring documentation and company processes remain compliant as new requirements arise; reviewing and preparing any responses to customers and quality, regulatory, and other compliance authorities related to inquiries about how product design, manufacturing, registration, distribution and sales satisfy applicable requirements.

PROVIDES STRATEGIC VISION OF THE RISK MANAGEMENT PROCESS BY:
Fully understanding and communicating the risk management requirements of ISO 14971, ISO 13485, and European Medical Device Regulation 2017/745 and other regulations as they apply to the company's products and processes; guiding the refinement of the risk management documentation process; advising the Quality Assurance/Regulatory Compliance (QA/RC) team in assessing and mitigating product, process, and Quality Management System risks; reviewing and approving risk management documentation, acting as a resource to other company functions for risk management activities.

ESTABLISHES RAW MATERIAL STANDARDS BY:
Evaluating product designs and assisting with the determination of key quality characteristics; determining risks associated with raw materials and components in order to support manufacturing processes; interacting with Supplier Quality when supplier quality related concerns arise; and approving testing methods and procedures.

MEASURES RESULTS BY:
Appraising, documenting, and reporting of quality trends, problems, and issues as they develop, including post-market feedback; reporting QA/RC department activities on a regular basis.

ESTABLISHES COMPLIANT QUALITY MANAGEMENT SYSTEMS BY:
Acting as Management Representative as defined by ISO 13485 and 21 CFR part 820 for the Belleville Site and acting as the Person Responsible for Regulatory Compliance as defined in European Medical Device Regulation 2017/745 for Belleville and New Berlin manufacturing locations; Managing the operation of QMS systems including internal auditing, product approval; post-market feedback; document control, corrective and preventive action, and quality records; supporting the operation of QMS systems including calibration and process and software validation; authoring top level policies and effectively communicates requirements to all employees.

ENSURES INTERDEPARTMENTAL COOPERATION AND SUPPORT BY:
Reporting to the V.P. of QA/RC; supporting the product development process and production operations; working closely with the process engineering team to implement new equipment, tooling, and processes and to optimize existing equipment and processes; coordinating efforts with counterparts and management in other Company production units, regions, and group functions.

INCREASES MANAGEMENT'S EFFECTIVENESS BY:
Recruiting, selecting, orienting, training, coaching, counseling, and disciplining department employees; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities.

ACCOMPLISHES SUBSIDIARY OBJECTIVES BY:
Establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections when needed; ensuring documentation is established for design transfer activities.%58047475%

Keywords: Permobil, Belleville , Quality Manager, Executive , Belleville, Illinois

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Illinois jobs by following @recnetIL on Twitter!

Belleville RSS job feeds