Quality Assurance Manager

Quality Assurance Manager

Would you like to work in an international environment where you'll make a difference every day? At Permobil, we're looking for game-changers to join us as we innovate for individuals and develop the world's most advanced assistive solutions.

At Permobil, the people who use our products come first. Our purpose is to create advanced assistive solutions that make the lives of adults and children living with disabilities more enriching. Our people are passionate about pushing the boundaries of technology to deliver innovations that improve lives. We are a sustainable and responsible business committed to continuous improvement, and our customers can trust us to provide market-leading solutions driven by insights-based clinical data. Our Quality Assurance and Regulatory Compliance department in New Berlin, WI is now looking for a Quality Assurance Manager.

Job
Purpose
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 requirements
necessary to register, distribute, and sell products including ISO 13485, FDA
QSR; and EU regulations.

Essential
Job Results

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.

Education
and Experience
Bachelor's Degree from college or
university, plus minimum of eight years related experience and/or training, including
four years of professional experience
in regulatory affairs or in quality management systems relating to medical
devices.

Why Permobil is a great next step for you!

1. You'll make a difference. Every day.

Everything we do leads to understanding and improving the lives of our users. Through our evidence-based innovation, we make a difference to people's lives.

2. You'll make your mark as part of our future

We collaborate with colleagues across borders to Innovate for Individuals. The impact you make personally could lead change around the world.

3. You'll feel welcome from day one

We're known for being great colleagues, who are collaborative, fun and at the cutting-edge. Everyone in the Permobil family cares as much as you do about making a positive difference.

4. You can have a lifestyle you love

In Lebanon you're always close to nature, yet never far from civilization. We want everyone who works for us to have a lifestyle they love - at work and beyond.

Who you are
You are passionate, innovative, and ambitious.
You want to make a difference for others and feel fulfilled when you can see
the link between the work you do and positive improvements in the lives of
others. You search out opportunities and are prepared to go off the beaten
track to chase your dreams. You don't follow the herd - you find new ways of
working and go where you see potential to make your mark. You are a pioneer, a
revolutionary, a game-changer and you are who we're looking for.

Information
Please apply via our career page. We will
conduct selection continuously so send us your application today!

For additional information about the position, please contact Manager title, Manager name, Manager Contact information.
For information about the recruitment process, please contact the recruiter, Recruiter Name, HR BP contact info.

For information regarding Permobil's Privacy Notice, please visit Permobil Candidate Privacy Notice

At Permobil, diversity fuels our innovation in creating life-changing mobility solutions. We embrace the unique talents and perspectives of individuals from all backgrounds to drive our mission forward. Join Permobil and be part of a team where diversity is not just valued, but essential to our success in delivering personalized mobility solutions.

Permobil is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Please respect that we do not wish recruitment assistance or advertising, we decline calls from recruitment and advertising providers.

Please respect that we do not wish recruitment assistance or advertising, we decline calls from recruitment and advertising providers.

More about Permobil

Permobil founder Dr. Per Udden believed that helping people achieve the greatest level of independence is a basic human right and, for over 50 years, Permobil has held fast to that belief. Permobil is a global leader in advanced rehabilitation technology, passionate about better understanding our users' needs and improving their quality of life through state-of-the-art healthcare solutions. Today, those solutions include power wheelchairs, seating and positioning products, power assist, and manual wheelchairs.

Permobil is part of Patricia Industries, a subsidiary of Investor AB, and is headquartered in Sweden. Permobil has 1900 team members in more than 18 countries around the world. For more information regarding the company's storied history and complete product line, visit permobil.com.