Are you looking for the right employment opportunity that not only has a great compensation package that is based on skills and experience but whose work is also meaningful? Join our Quality Team!
Who we are
Sunrise Medical is committed to improving people's lives by providing innovative, high-quality mobility products and services that exceed customer expectations. Sunrise Medical is a world leader in the development, design, manufacture, and distribution of manual and powered wheelchairs, mobility scooters, and both standard and made-to-order seating and positioning systems.
What we offer
Excellent health benefits plans, which includes FSA and HSA options
Life insurance
401(k) with company match
Generous vacation, paid sick time-off and paid holidays
Employee Assistance Program
Employee Resource Groups
Wellness programs and benefits
Education Reimbursement Program
Job Summary
Responsible for implementation of Quality Systems elements in accordance with FDA Quality Systems Regulations and ISO 13485 standards. Responsible for providing direct support of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management. Performs Regulatory activities to support legal/regulatory laws as appropriate for a medical device manufacturer in North America. Provides Regulatory oversight/expertise on all projects, as needed. Ensures timely investigation and response for product complaints and injury reports working collaboratively with other members of the organization to initiate and participate in investigations and corrective actions.
Principal Job Duties & Responsibilities
Work with Head of Quality and Regulatory to ensure all documentation is appropriate, complete and in compliance with all applicable regulations; prepare responses to the competent authorities requests.
Coordinate activities with appropriate departments (e.g., Product Management, R&D, Quality, Customer Service, etc.) to ensure conformity to applicable regulatory requirements in North America.
Develops and maintains procedures to document and clarify Quality/Regulatory processes.
Generates and contributes to fulfilling requirements of Postmarket Surveillance (PMS) obligations in conformance with (EU) 2017/745, SOR/98-282, 21 CFR 820.198, 21 CFR 822, and FDA Guidance: “Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act.” Also ensures supplements are filed in a timely manner with appropriate follow-up and complete and accurate reporting.
Lead effort for daily review of reported complaints and/or returns for trending and identification of potential regulatory reporting and corrective/preventive actions.
Leads product failure investigations and risk analysis activities as required.
Lead risk management activities in cooperation with product development teams on product enhancement projects and new product development initiatives for use-case scenarios.
Generate and file MDRs (Medical Device Reports – U.S.) or MPRs (Mandatory Problem Reports – Canada, in cooperation with Canadian head of regulatory) on time, as needed.
Lead and coordinate Document Control activities to support the Quality Management System.
Establish methods for data analysis and trending, along with appropriate trigger points.
Coordinate with appropriate departments the gathering and reviewing of data regarding market observations on company products as well as competitor products (similar products) for evaluating failure trends in product types.
Generate data and reports upon request, as well as supporting organizational KPIs or product improvements.
Manage QMS software system infrastructure, as well as actively participate in software validation / re-validation activities.
Evaluate proposed corrections and/or removals. Coordinate with Remedial Action Board and Global Regulatory Board for response to corrections and/or corrective actions. Participate in activities as determined by RAB and GRB.
Manage Recall/FSCA and track the status through completion.
Administers the Corrective Action Preventive Action (CAPA) system by working closely with suppliers and internal process owners to ensure appropriate corrective and preventive action is implemented.
Support department initiatives for maintaining current regulatory knowledge and communications.
Supports new product development activities, participating in project meetings, design reviews, risk management, and other activities as required by the Design Control Process.
Reviews Design History Files for accuracy and compliance to internal and FDA requirements.
Enter necessary data into the electronic databases, including the complaint management system.
Aid in liability claim investigation and document collection.
Participate in FDA/External/Internal Audits or inspections, as needed. Provides analysis of internal Quality issues and provides recommendations for improvements.
Mentors Quality Engineers, Regulatory Specialist, and technical staff.
Leads continuous improvement projects and identify opportunities for improvement in Quality and Manufacturing.
Provides Quality review and authorization for documentation changes to engineering prints, Quality Plans, manufacturing work instructions, process sheets and inspection plans. Provides Quality review for product design changes, as needed.
Works closely with Manufacturing and Manufacturing Engineering and product engineering in determining process capability and process validation, as needed.
Establishes Product Quality and Inspection Plans to manage in-process product evaluation points, levels and criteria, as needed.
Provides Material Review Board (MRB) disposition for nonconforming product, as needed.
Conducts or participates in supplier audit, qualification and certification, and re-evaluation activities as required.
Other special projects/assignments as designated by management.
Qualication:
Required Skills, Knowledge, and Experience
Bachelor of Science in an engineering discipline or equivalent experience. Mechanical, Manufacturing, Process or Quality Engineering Degree a plus.
Two plus years of relevant experience in a manufacturing or quality environment, with a specialty in Quality engineering or regulatory affairs required. Medical devices or wheelchair/mobility products experience a strong plus.
Experience with eQMS systems (e.g. Mastercontrol, etc) a plus.
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 preferred.
Knowledge of (EU) 2017/745 a plus.
Certified Quality Engineer, Six Sigma Green Belt, and/or Six Sigma Black Belt preferred.
Strong working knowledge of computer database systems, Microsoft applications, PC, and various software programs required.
Strong aptitude for problem solving, root cause analyses, and statistical analyses. Process/product validation experience.
Experience with Quality Risk Assessment tools such as HARMs, FMEA, HHE, HRA, CAPA, required.
Capable to present data (presentations) to management teams and train co-workers as needed.
Must have ability to properly interpret Engineering drawings and clearly present that information to others.
Ability to interface with a variety of associates with exceptional communication skills.
Must have ability to present data clearly and concisely.
Ability to travel to other Sunrise facilities to support quality audits and issues.
Competencies
Analytical Thinking – Approaching a problem by using a logical, systematic, sequential approach.
Building CollaborativeRelationships – Developing and maintaining partnerships with others.
Developing Others – Delegating responsibility and coaching others to develop their capabilities.
Diagnostic Information Gathering – Identifying the information needed to clarify a situation, seeking that information from appropriate sources, and using skillful questioning to draw out the information.
Forward Thinking – Anticipating the implications and consequences of situations and taking appropriate action to be prepared for possible contingencies.
Fostering Teamwork – As a team member, the ability and desire to work cooperatively with others on a team; as a team leader, interest, skill, and success in getting groups to learn to work together cooperatively.
Influence Skill – Gaining others’ support for ideas, proposals, projects, and solutions.
Initiative – Identifying what needs to be done and doing it before being asked to or required by the situation.
Oral Communications – Expressing oneself clearly in conversations and interactions with others.
Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable and trustworthy.
Persuasive Communication – Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
Providing MotivationalSupport – Enhancing others’ commitment to their work.
Results Orientation – Focusing on the desired end result of one’s own or one’s unit’s work; setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
Self Confidence – Faith in one’s own ideas and ability to be successful; taking an independent position in the face of opposition.
Written Communication – Expressing oneself clearly in business writing.
Physical Requirements
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
Fluency of Ideas — The ability to come up with a number of ideas about a topic.
Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Lifting/ Carry Weight - Must frequently move and lift up to 10 lbs. and occasionally lift and/or move up to 40 lbs.
Mathematical Reasoning — The ability to choose the right mathematical methods or formulas to solve a problem.
Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
Speech Clarity — The ability to speak clearly so others can understand you.
Speech Recognition — The ability to identify and understand the speech of another person.
Written Comprehension — The ability to read and understand information and ideas presented in writing.
Written Expression — The ability to communicate information and ideas in writing so others will understand.