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
Program Manager
This high visibility position must apply sound technical and business logic as a Project Leader. The Program Manager is responsible for establishing and meeting programs’ financial, quality and schedule targets. Accountabilities include effective communication with cross-functional teams and Management, identification and mitigation of program risks, and promoting world-class project management systems. Experience as a project manager of complex projects with demonstrated application of project management tools is an essential requirement.
Requirements include an Engineering degree or other college coursework for manufacturing technology. Additional college level coursework in business and management desirable. Eight years experience in technology-based manufacturing. Five years experience in the medical products industry. Proven success as a project manager of complex projects. PC skills including project and business office software.
Senior Network Administrator
You will be responsible for the maintenance of computer hardware and software. You will maintain HP Blade environments and deployment. Other duties will include configuring servers/applications, VMWARE and SANS.
Ideal candidate must possess BS in computer science with 5+ years experience as a network administrator. MS strongly preferred. Experience implementing multiple server environments a must. Strong hardware familiarity required. Strong organization skills needed. Excellent communication skills a must.
Process Development
Design Engineer
In this position, you will be responsible for developing capable process and ensuring efficient transfer of processes and product into production in a cost-effective manner. You will focus on metal joining, specifically with lasers. You will also design tooling and equipment along with processes for new product introduction. Other duties will include identifying/resolving issues, processing quotation requests, directing personnel and reviewing completed products.
Ideal candidate must possess and Engineering degree or other college degree related to manufacturing technology with 5-8 years experience in a manufacturing environment. Mechanical Engineering degree preferred. Experience with medical products a plus. Extensive knowledge of manufacturing equipment and tooling. Knowledge of Laser Processing including CO2, YAG TEA Excimer or other types of lasers.
Maintenance Mechanic III
2nd Shifts: 2:00pm – 10:00pm
This high level position will be responsible for performing skilled duties in the repair of manufacturing machines as well as general maintenance of the facility. Other duties will include waste management responsibilities, welding, plumbing, painting and carpentry.
Ideal candidate must possess a High Scholl diploma or GED with two-year Vocational Trade School degree and four years experience. Ability to read and understand blueprints a must. Working knowledge of computers and PLC needed. Excellent sketching skills required. Strong communication skills needed. Must be able to pass Mechanical Aptitude test.
Maintenance Mechanic II
2nd Shift: 2:00pm – 10:00pm
3rd Shift: 10:00pm – 6:00am
You will be responsible for performing skilled duties in the repair of manufacturing machines as well as general maintenance of the facility. Other duties will include waste management responsibilities, welding, plumbing, painting and carpentry.
Ideal candidate must possess a High School diploma or GED with one year trade school and two years experience. Industrial Electricity 1 & 2 coursework required. Ability to read and understand blueprints a must. Excellent sketching skills required. Strong communication skills needed. Must be able to pass Mechanical Aptitude test. Candidates must be flexible with 2nd and 3rd shift hours.
Toolmaker
2nd Shift: 2:30pm – 1:00am
Monday – Thursday
You will be responsible for planning, constructing and repairing a wide variety of intricate and complicated tools, dies, jigs, gauges and fixtures to extremely close tolerances. Other duties will include organizing workflow, performing close tolerance grinding/fitting and training employees.
Ideal candidate must possess a two-year vocational tool and die degree or five years related experience. High degree of experience and trade skill as well as thorough knowledge of tool making process required. Ability to set-up and operate all Toolroom equipment and accessories a must. Excellent problem-solving skills needed. |
New Ross, Ireland
Lake Region Medical Limited
Butlersland, New Ross
County Wexford Ireland
E-mail: HR@lakergn.com
Environmental Health and Safety Specialist
Contract (12 months)
The Contract EHS Specialist is required to over see, monitor and control all Environmental, Health and Safety activities in Lake Region Ireland to ensure conformance with all regulatory and legal requirements.
.
Accountabilities include:
- Health and Safety:
- Be very familiar and up to date on all Health and Safety regulations and legal requirements.
- Maintain an updated and satisfactory Safety Policy
- Ensure effective H&S training of all employees by facilitating training of Management, Supervisors, Team Leads, Trainers and Line Lead personnel.
- Monitor H&S performance throughout the plant through regular audits. Ensure speedy corrective action in the case of non conformances.
- Schedule regular fire drills and exercises to ensure highest state of readiness for evacuation for all employees in the event of a major emergency.
- Perform the function of Safe Area coordinator during drills and real emergencies.
- 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.
- Environmental Health
- Coordinate with management and supervisors to ensure compliance with all environmental policies and legislation
- Coordinate with management and supervisors to ensure compliance with ISO 14001 Environmental Management Systems
- Ensure regular monitoring of all chemical storage, chemical handling, effluent and stack emissions in accordance with policies to protect the environment.
- Support appropriate training programs for management and employees.
- Monitor and ensure adequate records are maintained.
- Ensure adequate briefing of management prior to all external communications.
- Ensure compliance with all waste legislation.
Minimum Education and Experience Requirements:
- Degree level in Environmental Health and Safety or a technical discipline with 1-2 years experience in a EH&S role.
- Good understanding of Irish legislation on health safety and environmental affairs.
Quality Engineer (Microbiologist)
The Quality engineer (microbiologist) will primarily be responsible for ensuring compliance to all relevant regulations for sterilisation and microbiology which includes maintaining all quality systems and related documentation.
Accountabilities include:
- Quality Engineering Responsibility in Packaging and Shipping
- Direction for quality in Packaging and Shipping covering
- Approval of the product from each area, by maintaining and developing the quality control process to ensure quality product is shipped to customer.
- Co-ordination and control of all related quality system elements for the areas, e.g. NCMTs, CAPA, customer complaints SCARs, internal audits, etc.
- Provision of the necessary reports on the above system.
- Ensuring all procedures relating to the above areas/systems are implemented and updated as required.
- Co-ordination and control of one of the key components of the quality system, i.e. Plant microbiologist covering sterilisation.
- Playing a role in the plant annual objectives.
- 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:
- FDA Quality System Regulation 21 CFR 820 (QSR)
- ISO13485 Medical Device Quality Management System
- ISO14971
- Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
- Process Validation Guidance from the Global Harmonization Task Force (GHTF) - July, 1999.
- Related sterilisation validation standards.
- Plant audits;
- 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.
Minimum Education and Experience Requirements:
- Engineering or science Degree.
- Qualification in microbiology is a must.
- A Six Sigma qualification will be a distinct advantage.
- 1-3 years experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment.
Procurement & Materials Manager
The Procurement & Materials Manager is responsible for the effective and efficient provision of all materials purchasing activities regarding materials and services and coordination of inventories and all associated activities regarding the production of quality product under current regulatory guidelines within budgetary guidelines to satisfy customer requirements.
Accountabilities include:
- Formulate, and implement a purchasing strategy that involves cost reduction programs/cost avoidance, strategic alliances and reduction of supplier base.
- Coordinate the procurement, delivery and expedition as required of quality materials and services to meet customer orders.
- Develop strategies and tactics to optimize pricing/delivery/inventory negotiations with suppliers that ensure continuous, expeditious supply of materials.
- Ensure that documented Quality Management System is representative of actual procurement/inventory management activities.
- In conjunction with others ensure proactive response to relevant customer complaints, whether internally generated or externally generated
- Effectively communicate procurement details to cross-functional groups and attend routine Operations / Cross – functional meetings.
- Review quality, efficiency and scrap reports as required where materials /services factors are potential causes of poor performance.
- Participates in visits/audits with global suppliers to evaluate and analyze supplier performance. Monitor and approve new vendors as required for approved Vendor list.
• Manage and maintain through departmental monitoring systems stocks of all spare parts and consumables. Manage inventories by recommending obsolescence, reduction and redistribution to meet business objectives.
- Ensure all required service and support needs are in place and underpinned with current contractual arrangements, where appropriate.
- Participates in the development and implementation of systems that measure, track; analyze supplier and material effectiveness, price and reliability. (Supplier Quality Rating)
Minimum Education and Experience Requirements:
- Third level Degree in appropriate Course of Study / Professional Certification Required
- 5 – 7 years relevant experience in hi-volume manufacturing procurement / materials environment.
- Proven ability in business tendering, negotiation situations and supplier management skills
- Good knowledge of MRP / ERP systems
- Awareness of production capacities, efficiencies, plant economies and constraints.
- Record of success in Continuous Improvement Activities.
- Knowledge of ISO 9000 or equivalent documented quality systems.
- Knowledge of GMP and operating in Regulated Health Care environment.
|
