Robling Medical, Inc. is currently searching for the following positions. With a great culture and strong leadership, we are making a positive difference in patients’ lives everyday.
Open Positions
General Summary
The Maintenance Mechanic will maintain production equipment to support the requirements of Operation and Production. Support and assist with the installation, testing and validation of new production equipment. Maintain an adequate inventory of tools and parts necessary to effectively perform duties.
Primary Duties and Responsibilities
- Perform Preventive Maintenance (PM) and repair of production equipment in accordance with OEM specifications, OSHA and cGMP requirements.
- Maintain organization, cleanliness and safety of assigned areas of responsibility
- Maintain adequate spare parts to perform PM on assigned equipment
- Complete all necessary operational training on equipment
- Assist Manufacturing Engineering with installation, testing and validation of new production equipment
- Perform basic repairs and improvements to facility systems as needed
- Perform any additional duties as assigned by Management
- Flexibility in work schedule with ability to work overtime as necessary
Required Skills
- Ability to effectively use Test, Measurement and Diagnostic Equipment (TMDE)
- Reading, writing and relevant Math skills required
- Basic experience in skilled trades. (carpentry, plumbing, etc)
- Ability to use Office, Word, Excel and other spreadsheets.
- Excellent written and verbal communication skills
- Ability to walk, kneel, stand frequently or for long periods
- Ability to climb and work from ladders
- Must be a team player
- Basic knowledge of tools and proper usage
Education
- High School diploma or GED required
Preferred Qualifications
- Associates or Certificate in Mechanics, Electronics, or related field
- Experience maintaining and troubleshooting various forms of equipment
- Medical or pharmaceutical manufacturing experience.
Environment & Working Conditions
This position is generally performed indoors in a plant or office environment (but may require outside work as well) and requires specific physical requirements that must be met, including:
- Some heavy lifting and considerable moving of equipment (regularly lifting up to 25 pounds)
- Standing for long periods of time
- Sitting as needed
- Climbing, bending, stooping, kneeling, crouching
- Ability to lift up to 50 pounds
- Exposure to a combination of normal office type environments, along with activities in the plant
- Regularly exposed to dust, odors, non-hazardous chemicals, fumes and noise
- Vision – both close and distant vision skills necessary
- Ability to use hands and fingers; reach with arms; feel parts and other items as needed for the position.
- Ability to work in adverse weather conditions as necessary for emergencies.
General Summary – Responsible for serving as a member of a Cross Function Customer Focus team and assisting the QA Manager in the maintenance of the Quality Management System. Responsible for assuring compliance with Quality System Procedures through the support of QA personnel.
Primary Duties and Responsibilities
- Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.
- Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.
- Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.
- Lead in the development and maintenance of Limit Samples and other inspection aids
- Lead all Risk Assessment activities
- Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner
- Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented
- Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.
- Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives
- Provide interface and communications with customer and suppliers on all quality concerns.
- Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices
- Review and approve Validation Protocols and Reports
- Assist in the execution of Validation activities as required.
- Interfaces with Suppliers regarding incoming quality issues
- Performs Supplier Audits
- Conducts Internal Audits
- Other duties as assigned
Required Qualifications
- 4 year BS degree or equivalent applicable experience
- Proficient in the use of Quality Management Tools
- Proficient in MicroSoft Office Suite
- Strong writing skills
- Strong verbal communications skills
- Proficient in interpretation of regulatory requirements and standards
- Strong Analytical skills – Cause and Effect Analysis
Preferred Qualifications
- ISO 9001 or ISO 13485 Certified Auditor
- Experience in the performance of Supplier Audits / Evaluation
- Experience in the appropriate selection of Statistical Tools
Environment & Working Conditions
- Lifting – 30 lbs
- Ability to work in a cleanroom environment
- Standing for long periods of time
- Bending
- Sitting for long periods of time
- Visual – Constant Visual attention
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