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Compliance Engineer - Medical in Bentonville, AR at Carlisle Interconnect Technologies

Date Posted: 1/9/2019

Job Snapshot

Job Description



SUMMARY
The medical Compliance Engineer will provide support and project management for quality, compliance and engineering functions within Carlisle Medical Technologies Dongguan China and Kent locations with focus on compliance and quality programs. Analyze data and lead efforts to identify and permanently implement corrective actions by eliminating root causes. Support compliance to ISO13485 Quality System and 21 CFR Part 820 with emphasis on corrective actions (poke-yoke development, process development and reporting). Lead and participate in structured system and process auditing, problem-solving teams and apply statistical and other problem-solving tools.

ESSENTIAL JOB FUNCTIONS


• Project Management for implementation of critical compliance and quality improvement projects.

• Apply problem-solving techniques and cross functional activities to resolve significant problems

• Assist with third party Certification and regulatory inspections through:


• Compliance Audits for ISO13485 and 21 CFR Part 820

• Global CAPA Administration- Evaluate corrective and preventative action plans and implementation effectiveness.

• Participate and lead cross training on processes and best practices for medical.

• Conduct and/or participate in activities such as Process FMEA's, Design of Experiments, Process/Product Capability Studies, Process Validations, etc.

• Evaluate manufacturing problems, product problems and customer complaints to determine opportunities for improving manufacturing and product quality.

• Participate in supplier audits for medical as requested by management.

• Participate in the development of Quality Strategic Planning, Defining or Developing - Cost of Quality, Future Role of Quality, Measuring Quality as directed by management.

• Travel to China, Kent, Customers and Suppliers as requested by management.


•Other duties as required in support of the department and the company

WORK ENVIRONMENT
The position will be home based. The work environment characteristics described here are representative of those an employee encounters while traveling and performing the essential functions of this job. Work is performed in a normal office environment with minimal physical risks involved. The noise level in the work environment is low to moderate

ENVIRONMENTAL POLICY
Carlisle Interconnect Technologies is dedicated to identifying and reducing the environmental impact of its operations, activities, and products. It is our commitment to comply with all applicable laws and other regulatory requirements concerning the environment. We are committed to preventing pollution and continually improving our environmental performance in all of our global operations. This will be achieved through a comprehensive Environmental Management System that provides the framework for setting and reviewing environmental objectives and targets of Carlisle Interconnect Technologies

PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS


• Clear ANSI Z87.1 safety rated glasses are required for the job when in the manufacturing areas

EXPORT COMPLIANCE DISCLAIMER
This position includes access or potential access to ITAR and/or EAR technical data. Therefore, candidates will need to qualify as a US Person which is defined as a US Citizen, or a Permanent Resident (Green Card Holder)

TRAVEL
0 - 50%


QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential job function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions


• General understanding of Quality Assurance Systems and Applications; such as ISO13485 and 21 CFR Part 820.

• Experience working in Medical Manufacturing environment

• Computer literate

• Problem solving

• Good communication skills

• Communicate with other associates and provided training as required

EDUCATION and/or EXPERIENCE


• B.S. Engineering Degree (Metallurgical, Electrical, Quality or Mechanical) preferred

• Three years' experience in Quality Engineering in a manufacturing environment

• Certified Quality Engineer and/or Certified Quality Auditor preferred

CERTIFICATES, LICENSES, REGISTRATIONS
Must maintain industry certifications as applicable to position and value stream that is supported. Including but not limited to; IPC-WHMA-A-620, IPC-JSTD-001, IPC-610, IPC-600

LANGUAGE SKILLS


• Ability to read, write, speak and understand English

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions


• Regular sitting, standing and walking throughout the day to accomplish tasks

• Occasional sitting

• Manual and finger dexterity used regularly with some repetitive finger motions, and required usage of both hands as needed

• Lifting and carrying up to 25 pounds, occasionally up to 50 pounds

• Specific vision abilities include close and distance vision; able to identify colors, small letters and numbers; hand/eye coordination, depth perception and able to adjust focus

• Hearing and speaking

• Other conditions may include frequent reaching, stretching, pushing, pulling, pinching, grasping, gripping, and crouching or stooping

• This position may/may not require passing annual eye testing as required by customers for production activities. If required, exams will be provided by a medically qualified/trained person and shall be paid for by the company
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled