Smiths Medical is currently hiring a Quality Systems Specialist in Minneapolis, MN.
The Quality Systems Specialist will perform quality systems work requiring full competency in all conventional aspects of quality systems in regards to the processes and products relating to disposable and/or reusable sterile and non-sterile products, components, or medical devices manufactured within a controlled or cleanroom environment.
Smiths Medical has a positive impact on someone's life around the world every minute of every day. In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels. Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline.Duties & Responsibilities
- Assist in driving improvement with QMS Compliance and reduction of cost of quality in purchased materials, purchased goods, and manufacturing processes. In particular processes supporting supplier management, support internal & external quality audits, CAPA, component compliance and all QMS compliance activities.
- Participates in the Internal Audit Process.
- Follow-up on internal audit reports and corrective actions.
- Supports the QS Manager for external audits by regulators such as Notified Bodies, FDA, customer site audits and Smiths Medical Group Regulatory Affairs audits.
- Assists in developing the corrective action plans for any findings resulting from external audits.
- Monitors and reports progress on corrective action plans.
- Complete customer questionnaire information including manufacturing plant and product data as requested, work closely with global customer inquiries to achieve a timely response.
- Identify opportunities to streamline QMS processed and procedures.
- Ensures all applicable external standards are available.
- To assure regulatory and company policy compliance of all quality system activities with regards to QMS.
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.The Individual
- Less than University Degree (Associate degree) or technical equivalent required.
- Two year technical/vocational diploma in Quality Assurance, Quality Control, Computer Science, or related field.
- Proven experience in quality assurance or quality control in a medical device or similar regulated environment required.
- Knowledge of GMP requirements and previous database management experience is required.
- Applicable technical qualifications preferred.
- Demonstrated excellent verbal communications skills and technical writing ability. Able to plan and conduct effective meetings and group presentations. Able to provide technical presentations to internal and external audiences.
- Skills in developing training programs to meet individual needs.
- Excellent interpersonal skills to interface with all levels of company structure as well as representatives of outside agencies or companies.
- Good decision making and problem-solving skills.
- Demonstrated flexibility and resilience in the face of constraints, frustrations, or adversity.
- Education requirements can be obtained through an educational institution or gained through equivalent work experience.
In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!About Smiths
At Smiths we apply leading-edge technology to design, manufacture and deliver market-leading innovative solutions that meet our customers' evolving needs, and touch the lives of millions of people every day. We are a FTSE100, global business of around 23,000 colleagues, based in 55 countries. Our solutions have a real impact on lives across the planet, enabling industry, improving healthcare, enhancing security, advancing connectivity and supporting new homes. Our products and services are often critical to our customers' operations, while our proprietary technology and high service levels help create competitive advantage. We welcome colleagues with a curious mind, who are happy with responsibility, enjoy a challenge and are attracted by the idea of working at a business with an almost 170 year history of innovation, and five global divisions, all experts in their field.About Smiths Medical
Smiths Medical is always looking for people with a passion to positively impact the health and wellbeing of people around the world. If you have a curious mind, relish a challenge and want to make a difference then bring your talents here and your opportunities are endless. We're proud that we've been helping propel the human world forwards during our 160-year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big we have introduced some of the most trusted brand names in healthcare. Today we're an aligned global business 8,000 colleagues, that touches the lives of 7 people every second across the globe. So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.
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