Chaska, Minnesota
Lake Region Medical
Attn: Human Resources
340 Lake Hazeltine Drive
Chaska, MN 55318
Fax: 952-448-1751
Job Line: (952) 448-5111, extension 2532
E-mail: BISmith@lakergn.com
Senior JDE Business Systems Analyst
This position is responsible for implementing information needs of LRM on a global basis and improving our business processes and technology to accomplish the objectives of the business. Specifically the incumbent is expected to work closely with the business community to improve productivity, reduce costs and improve customer satisfaction by leveraging JDE.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Employees are expected to support the quality concepts inherent in the business philosophies of Lake Region Manufacturing, Inc., including a variety of job related tasks which may not be specific to this position profile. This position requires complete confidentiality due to the system information contents.
Accountabilities Include:
- Develop and implement project plans, which include definition, scope, resources and schedule that will satisfy the global business needs.
- Define and prioritize projects and tasks in order to achieve company objectives. Ensures adequate communication is maintained regarding all project status and priorities.
- Lead process work teams in learning and developing new process solutions.
- Assess the needs and provide creative solutions to our global operations, and also contribute ideas to improve the function, reliability and quality of services.
- Create standards and procedures for business automation processes.
- Maintain a professional awareness of tools and techniques that might be used to improve the quality of service.
- Implement solutions that must satisfy the business needs for the future, i.e., and take into account company growth and customer service objectives.
- Evaluate existing procedures and implement timesaving methods.
- Direct departments in identifying methods for improving effectiveness and efficiency through the use of automated resources, i.e. manufacturing software etc.
- Create and conform to project guidelines, schedules and deadlines.
- Propagate detailed processes and procedures, in accordance with MIS policies and practices, for use and implementation of new process tools.
- Performs other responsibilities and duties as reasonably assigned.
SKILLS AND KNOWLEDGE:
- B.S. in Computer Science or business field, Masters Degree preferred.
- Ten years experience in information systems supporting a manufacturing environment with JDE experience. Subject matter expertise in finance, distribution, manufacturing or procurement.
- Strong organizational skills to manage multiple, complex projects, analytical skills, verbal and written communication skills.
- Ability to establish and maintain credibility with all levels of management: knowledge of company long-term objectives.
- Demonstrated willingness to challenge established practices and draw relevant conclusions.
- Ability to take initiative and be creative in problem solving.
PHYSICAL DEMANDS:
- Operate business computers.
- Limited lifting required (up to 30 pounds).
- Travel between buildings often necessary.
- Travel out of state occasionally may be required.
MENTAL DEMANDS:
- Ability to manage a diverse workload, multiple priorities and professional staff.
- Must be well organized, accurate, and a self-starter who remains calm and flexible under pressure.
- Interpret the needs of internal customers.
WORKING CONDITIONS:
- Standard Office Environment.
- Exposure to manufacturing areas (none exceed OSHA guidelines for safety).
- Regular and timely attendance is required.
- Will be required to work outside of regular working hours on an as needed basis.
REPORTING RELATIONSHIPS:
- This positions reports directly to the Director of Corporate Information Technology.
Help Desk Associate II
Department: Information Systems
Position Reports To: Director, Corporate IT or Supervisor, Help Desk (as assigned)
Provide technical support to end users inclusive of software, peripheral devices, time and attendance hardware, and phones. Will isolate, resolve and follow-up on problems of a high level of complexity.
Essential Job Duties and Respoinsibilities:
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.
Responsible for identifying, prioritizing, and resolving reported problems. Responsible for solving routine software, hardware, and procedure problems using appropriate resources including but not limited to computer, Internet, and manuals. Communicate with I.S. staff, computer users, supervisors, and managers to determine requirements for new or modified software and hardware.
Emphasis may be in one of these areas although not to the exclusion of other areas:
1. PC support
Primary responsibilities include managing PC rollout, imaging and configuration. Help Desk support with an emphasis on PC imaging and configuration, Thin Client management, OS updates and changes, inventory receiving and tagging of equipment.
2. Organizational Support
Primary responsibilities include maintaining documentation, forms processing, and inventory records. Help Desk support with emphasis on maintaining I.S. documentation (SOPs), I.S. Forms processing, Inventory verification and regulation, maintenance agreement tracking, software license tracking, purchasing and finance department liaison, lease processing, form development and support.
3. Applications Support
Provides primary support on multiple applications such as finance, CAD, and/or database. Help Desk support with an emphasis on multiple applications such as CAD, database, finance, Minitab, Network support, production support specialist, and exception support.
4. Telecommunications Support
Primary responsibility for telephony, cellular, network, wireless and other data services.
5. Call Center
Answers user calls for support, assigns priorities, dispatches help desk staff. Provides limited phone support for problem resolution.
Accountabilities Include:
- Responding to all requests for assistance as directed by IT Management or call center dispatcher.
- Resolve user issues.
- Maintaining call logs.
- Responsible for documentation of equipment and software installed.
- Maintain operating procedure documentation.
- Maintain reasonable response times for user problems and resolutions.
Skills and Knowledge:
- Two year degree required; Bachelor's degree preferred. Alternately, two years of directly related experience may be substituted for each year of education.
- Minimum of four (4) years experience in help desk and/or PC support roles.
- Ability to grasp global corporate perspective in defining priorities.
- Good organization and time management skills.
- Good communication skills, both written and verbal.
- Must work well with others in a team environment.
- Ability to work independently.
- Ability to multi-task.
- Must be a logical thinker with good reasoning skills.
- Able to maintain confidentiality.
- Must work well with all levels of employees.
Physical Demands:
- Operate business computers.
- Limited lifting required (up to 30 pounds).
- Travel between buildings often necessary.
- Travel out of state occasionally required.
Mental Demands:
- Proven ability to manage a diverse workload and multiple priorities.
- Must be well-organized and able to carry out assignments in a timely manner.
- Must have the ability to remain calm and flexible under pressure.
- Interpret the needs of internal customers.
Working Conditions:
- Regular and timely attendance is required.
- Position must be able to work effectively with minimal supervision.
- Will be required to work outside of regular working hours on an as needed basis.
Reporting Relationships and Presence of Supervision:
- This position reports directly to the Director, Corporate Information Technology or Supervisor, Help Desk (as assigned). The position requires a high degree of self-discipline a minimal supervision.
Design Assurance Engineer
Department: Product Assurance
Position Reports To: Product Assurance Management
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Calibration Engineer
Department: Quality
Position Reports To: Quality Manager
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Machine Maintenance Mechanic
weekend shift - Friday, Saturday and Sunday 6 am – 6 pm
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New Ross, Ireland
Lake Region Medical Limited
Butlersland, New Ross
County Wexford Ireland
E-mail: acarney@lakergn.com
Senior Quality Engineer/Microbiologist
Location: New Ross, Co Wexford Ireland
The Senior Quality Engineer will primarily be responsible for ensuring compliance to all relevant regulations for sterilisation and microbiology which includes the maintaining all quality systems and related documentation.
Accountabilities include:
- Quality Engineering Responsibility in Packaging and Shipping
a. Direction for quality in Packaging and Shipping covering
i. Product approval of the product from each area
ii. Co-ordination and control of all related quality
system elements for the areas, e.g. NCMTs, CAPA,
customer complaints SCARs, internal audits, etc.
b. Co-ordination and control of one of the key components
of the LRI quality system, i.e. Plant microbiologist covering
sterilisation.
- Responsible for the organisation, training and direct supervision of the packaging quality inspectors.
- Liaise with production departments to ensure free flowing production system and timely shipment of product.
- Ensuring continuous compliance with the following:
a. FDA Quality System Regulation 21 CFR 820 (QSR)
b. ISO13485 Medical Device Quality Management System
c. ISO14971
d. Pertinent sections of the Japanese MHLW Ministerial
Ordinance No. 169 and product related standards
e. Ensuring continued compliance with DMR
f. Process Validation Guidance from the Global Harmonization Task Force (GHTF) - July, 1999.
g. Related sterilisation validation standards.
- Plant audits;
a. Interacting and presenting sterilisation and microbiological
documentation during FDA, NSAI, Corporate and
customer audits.
- Conduct training in sterilisation and microbiological and related procedures as required.
- Drive the site validation for sterilisation, including all liaising with the contract steriliser.
Educational Requirements:
- Engineering or science Degree.
- Qualification in microbiology is desirable
Experience :
- Several years experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
Applicants should submit a CV to acarney@lakergn.com or send to Amanda Carney, HR Department, Lake Region Medical, Butlersland, New Ross, Co Wexford
Environmental Health and Safety Specialist
Location: New Ross, Co Wexford Ireland
Reporting to the EHS Manager, the EHS Specialist is required to oversee, monitor and control all Environmental, Health and Safety activities in Lake Region Ireland to ensure conformance with all regulatory and legal requirements.
Accountabilities include:
- Coordinate with management and supervisors to ensure compliance with all environmental, health and safety policies and legislation
- Ensure effective EH&S training of all employees by facilitating training of Management, Supervisors, Team Leads, Trainers and Line Lead personnel.
- Monitor EH&S performance throughout the plant through regular audits.
- Schedule regular fire drills and exercises to ensure highest state of readiness for evacuation for all employees in the event of a major emergency
- Coordinate continual improvement programs on emergency response programs
- Carry our regular risk assessments on all equipment, ergonomic, VDU and working at height risk assessments
- Ensure adequate monitoring of all significant safety risks through out the plant including, ergonomics, hazardous environments, chemicals, fumes vapours, noise, mechanical, electrical, biological, and radiological exposures
- Organise and chair regular safety committee meetings
- Ensure regular monitoring of all chemical storage, chemical handling, effluent and stack emissions in accordance with policies to protect the environment
- Ensure compliance with all waste legislation
Minimum Education and Experience Requirements:
- Degree level in Environmental Health and Safety
- Minimum 3 years experience in an EH&S role in a manufacturing environment
Interested candidates should submit a CV to acarney@lakergn.com |
