**At Integer, our vision and values are embedded in everything we do!**
**If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!**
The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
**ESSENTIAL JOB DUTIES AND RESPONSIBILITIES**
Employees are expected to support the quality concepts inherent in the business philosophies of Lake Region Medical, including a variety of job related tasks which may not be specific to this position profile.
+ Ensure continued compliance with all Regulatory Standards. This includes:
+ ISO 13485
+ FDA QSR
+ ISO 14000
+ Lake Region Medical Policies and Procedures
+ Ensuring continued compliance with DMR
+ Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
+ Trend analysis of data from the controls
+ Potential improvements for review with engineering based on the trends.
+ Areas for Improvement to senior management.
+ Review and propose changes to sampling plans based on trend analysis and changes to the system.
+ Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
+ Support the Complaint/CAPA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
+ Execution of Quality Validations and preparation of associated documentation as required.
+ Review, update and approve Quality procedures as required through ECO process.
+ Action NCR and CAPA in an appropriate and timely manner.
+ Raise appropriate Variation Permits as required, in line with customer and regulatory requirements.
+ Support Customer and Regulatory Audits.
+ Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
+ Engineering Change Order (ECO).
+ Complaint/Corrective and Preventative Action (CAPA).
+ Material Review Request (MRR).
+ Internal Audits.
+ Failure Mode Effect Analysis (FMEA).
+ Variation Permits (VP).
+ Project meeting attendance and provision of quality support as required.
+ Attend and participate in daily cell meetings.
+ Preparation of information for KPI and Management Review meetings.
+ Be an active member of the Lake Region Medical Limited team and work with all employees to develop a world class lean manufacturing system.
+ Comply with the Lake Region Medical Limited behavioural standards.
**SKILLS AND KNOWLEDGE:**
+ Ability to communicate and work with people inside and outside the department.
+ Good communicator (written and oral).
+ Ability to train and lead where required.
+ Ability to co-ordinate, plan and organise in a timely manner.
+ Knowledge of engineering theories and methods.
+ Good technical report writing skills.
+ Rigorous attention to detail. **MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:**
+ Engineering or science Degree preferably with Quality Engineering included.
+ Quality Department or similar experience in regulated industry.
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy, gender, and gender nonconformity), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at