Do you have experience in quality and 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 & Regulatory 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
The Senior Quality Engineer is primarily responsible for implementation of Quality Systems elements in accordance with FDA Quality Systems Regulations and ISO 13485 standards. Responsible for providing direct support and oversight of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management. Provides overall leadership in production and people management within his/her area of influence.
Principal Job Duties & Responsibilities
Provide communication link between operations and engineering. Work with engineering to develop engineering process validation, product and component test methods, inspection guidelines and quality system procedures.
Manage sampling inspection, and testing of received parts, components, and materials to determine conformance to standards, also work with suppliers on quality improvement initiatives.
Develop the plant quality framework that includes integration of quality systems meeting ISO and all regulatory requirements.
Manage applicable internal audit requirements and process validation requirements supported by data analysis and corrective action reporting to establish consistent adherence to quality systems and support troubleshooting by the plant.
Establish and lead a quality staff with skills and abilities to become a true service organization to support the plant in training and technical troubleshooting to achieve plant and company goals.
Responsible for managing Associates through hiring, training, performance management, motivating and overall supervisor responsibilities.
Work cooperatively with Quality leads in all SRM facilities globally for consistency of process and on-going continuous improvement activities Supports new product development activities, participating in project meetings, design reviews, risk management, and other activities as required by the Design Control Process.
Participates on Build-4-Me Product Development and Manufacturing team to assure that all quality and regulatory issues are addressed for customer requested modification.
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.
Works closely with Manufacturing and Manufacturing Engineering and product engineering in determining process capability and process validation.
Establishes Product Quality and Inspection Plans to manage in-process product evaluation points, levels and criteria.
Leads product failure investigations and risk analysis activities as required.
Qualication:
Required Skills, Knowledge, and Experience
Bachelor of Science in Mechanical Engineering or related field.
Four plus years of relevant experience.
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 preferred.
Certified Quality Engineer and/or Six Sigma Black Belt Certification a plus.
Knowledge of computer database systems, Microsoft applications, PC, and various software programs preferred.
Strong aptitude for problem solving, root cause analyses, and statistical analyses. Process/product validation experience.
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
Initiative – Identifying what needs to be done and doing it before being asked to or required by the situation.
Providing MotivationalSupport – Enhancing others’ commitment to their work.
Managing Performance – Taking responsibility for one’s own or one’s employees’ performance, by setting clear goals and expectations.
Persuasive Communication – Planning and delivering oral and written communications that are impactful and persuasive with their intended audiences.
Analytical Thinking – Approaching a problem by using a logical, systematic, sequential approach.
Forward Thinking – Anticipating the implications and consequences of situations and taking appropriate action to be prepared for possible contingencies.
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.
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.
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.
Developing Others – Delegating responsibility and coaching others to develop their capabilities.
Building CollaborativeRelationships – Developing and maintaining partnerships with others.
Influence Skill – Gaining others’ support for ideas, proposals, projects, and solutions.
Self Confidence – Faith in one’s own ideas and ability to be successful; taking an independent position in the face of opposition.
Personal Credibility – Demonstrated concern that one be perceived as responsible, reliable, and trustworthy.
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.
Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
Written Comprehension — The ability to read and understand information and ideas presented in writing.
Language Requirement — Must be able to read, write, speak, and understand English.
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.
Speech Recognition — The ability to identify and understand the speech of another person.
Selective Attention — The ability to concentrate on a task over a period of time without being distracted.
Lifting/ Carry Weight - Must frequently move and lift up to 10 lbs and occasionally lift and/or move up to 40 lbs.
