QA Specialist

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.

As a member of global quality, team members will ensure that the quality management system is and remains compliant with current regulatory and international standards requirements. Team member will also help drive improvements within the quality management system which support the organizations business goals.

The QA/RC Specialist is responsible for the implementation, management, and compliance of the Pasco Quality Management System (QMS) Program. This role ensures a robust and compliant QMS process that complies with medical device domestic and international regulatory requirements and company procedures. The position is responsible for executing the QMS strategy and facilitating QMS integration with cross-functional processes. The role will also provide Quality Assurance support to supplier selection and qualification processes.

Essential Functions and Duties:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues to ensure compliance with ISO 13485 and FDA GMP requirements.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
• Support and assist teams associated with the Corrective Action Preventative Action (CAPA) System.
• Assist nonconformance investigate identified within the receiving and production processes.
• Investigate and trend complaints and customer feedback.
• Identify and execute any Medical Device Reporting (MDR) or other regulatory reports.
• Assist in the implementation and maintenance of a Post Market Surveillance system.
• Support tracking and reporting of Key Performance Indicators (KPIs) and other metrics associated with the performance of the QMS.
• Perform and support internal quality audits.
• Support the response to regulatory surveys and inquires.
• Support Market Corrections and Recalls.
• Supports regulatory inspections and inspection readiness activities.
• Review of Engineering Change Orders (ECOs) and perform the necessary quality assessments for all related design and document changes as applicable Standard Operating Procedures (SOPs) and regulations.
• Maintain professionalism at all levels in the organization.
• Other duties and responsibilities as assigned. Duties and responsibilities may change from time to time.

Qualifications:

• Bachelor’s Degree in a Science, Engineering, or related discipline.
• Two years of professional experience in a manufacturing environment preferred.
• Working knowledge of appropriate medical device regulations, requirements and standards such as ISO 9001, ISO13485, QSR, MDR.
• Strong oral and written communication, collaboration, and interpersonal skills with the ability to influence others, facilitate team interactions, and partner with key stakeholders.
• Ability to plan, organize, and implement multiple concurrent tasks.
• Ability to work independently and collaboratively.
• Excellent computer skills, including proficiency with Microsoft Office Suite (Word, Excel, etc.)

Salary: Exempt position - range $60,000 - $70,000 annually, paid bi-weekly

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

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.

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 Uddén 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 1600 team members in more than 15 countries around the world. For more information regarding the company’s storied history and complete product line, visit permobil.com.

Fun facts about us: One of our products was 1 of 100 best inventions in Time magazine in 2021
https://time.com/collection/best-inventions-2021/
https://time.com/collection/best-inventions-2021/6112517/permobil-explorer-mini/