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Document Control Specialist
Summary: Compiles and maintains controlled records and related files to release work orders, drawings, and engineering documents to manufacturing and other operating departments by performing the following duties.
High School Diploma, but would prefer either Associate's degree/Bachelor's degree or 2+ years related experience (preferred) and/or training; or equivalent combination of education and experience.
Must be able to lift approximately 50lbs.
Proficient in Microsoft Office, Excel, PowerPoint, etc.
XA/PowerLink knowledge and experience preferred.
Excellent written and verbal skills.
Must be detail oriented, thorough, and be able to multi-task as well as prioritize.
Must be a team player.
Hours 8am - 5pm - Monday thru Friday
Ability to travel if necessary.
Product Change Requests (CRs) Obtain approvals Process the change(s) in PowerLinkScan completed CRs along with all supporting documentation to WebDocs.File CRs for the current year.Box previous years CRs to be kept in storage for the total retention period per QA-C-700-3.Send Vendor Notification forms to vendors along with new and/or revised drawings or purchase material specifications.
Document Change Requests (DCRs) Prepare document changes in Microsoft Office/Word and/or Excel. Email to applicable personnel for initial review. Once initial review is complete; upload into Entropy for approval.Once the document is approved and “Published” via Entropy, move the copy from signatures to Docctl and move the obsolete copy to the Obsolete Documents folder on the network.Update the status report which lists current version number.
Instructions for UseCreate and revise Instructions for Use.Obtain quotes for translation of Instructions for Use (we currently have IFUs in 16 different languages).File all current IFUs in Document Control.
External Regulations and StandardsOrder regulations and standards via the internet.Download new/revised standards to the network for easy access for all employees.Scan hard copies of regulations/standards that cannot be downloaded from the supplier’s website. Update the log when new or revised standards are obtained.
Quality RecordsProvide all departments with labels for the contents of their boxes to be kept in storage.At least yearly box work orders.At least yearly box CRs.Maintain the Record Storage Log on the network.Communicate with shipping personnel to retrieve archived documents from the warehouse, when necessary.Scan/upload work orders to web-docs.
Project Engineer
Summary: Medcomp is a developer of World Class medical devices located in Harleysville, Pa and currently searching for Project Engineers. We are looking for a dedicated individuals to lead all activities required for the development, manufacturing, release and launch of new products.
Qualified applicants must be hands on, detail oriented, hold a Bachelor's Degree in an engineering discipline with 2 + years of related medical device experience preferred.
There is no relocation assistance or Visa sponsorship available for this position.
Please send salary requirements with resume.
Job Type: Full-time
Medical device: 2 years
Bachelor's
Lead Engineer
Summary: Medcomp is a leader in the Medical Device industry and in search of a seasoned Lead Engineer. This position will ensure engineering design deliverables have been completed for the development, manufacturing, release and launch of the team's assigned projects. The Lead will be responsible for directing and participating hands-on with the team to complete the design, analysis, prototyping, testing and validation of the product to assure that all design control activities are completed in accordance with cGMP, FDA, ISO 13484 CFR 21 part 820, MDD, EU and QMS.
Seasoned professionals are required to possess at minimum a four-year degree in an engineering, scientific or technical discipline.
Prior management or leadership experience is preferred.
Attention to detail and organizational skills are a must.
Ability to be a team-player and work cohesively with all levels of staff members and multiple internal and external departments.
Working knowledge of all regulations required by regulatory agencies.
Prefer 5-7 years' experience in the Medical Device industry.
Six Sigma Green Belt is preferred.
5-7 years in an engineering environment, designing, specifying, assembly and validating.
Excellent written and oral communication skills.
Problem-solving ability.
Travel at minimum 5%.
Must be proficient with Solid Works.
Must have experience with risk analysis tools, such as FMEA.
Must have experience with project management.
Relocation assistance and Visa sponsorship are not available for this position.
Job Type: Full-time
Medical devices: 5 years
Engineering: 5 years
Bachelor's
Medical Writer
Summary: Medcomp is a leader in the Medical Device industry and in search of a seasoned professional Medical Writer to use scientific/engineering knowledge and writing skills to effectively and clearly communicate technical medical science information. This position will author and participate in the generation of Medical Device Clinical Evaluation Plans and Reports, Literature Review Reports, Post Market Reports, Periodic Safety Update Reports, and Clinical Summary Reports for regulatory submissions. Also participate in writing of Health Hazard Evaluation and Risk Management documentation.
Minimum of a Bachelor's degree in English, Engineering, Life Sciences, or Health Sciences.
At least 5 years of experience in the Medical Device industry.
Minimum of 3 years recent experience writing Clinical Evaluation Reports.
Experience writing Clinical Trials Summary Reports a plus.
Knowledge of research methodology, including clinical investigation design and biostatistics preferred.
Must have a strong understanding of medical terms and be able to use diagrams, anatomical images, photographs or charts to explain medical content.
Knowledge of clinical dialysis, fluid infusion, and fluid drainage procedures a plus.
Working knowledge of ICH-GCP and EU Medical Device Directive/Medical Device Regulations.
Writing samples may be requested during the interview process.
This position has the potential to work remotely.
Relocation assistance and Visa sponsorship are not available for this position.
Job Type: Full-time
Writing Clinical Evaluation Reports: 3 years
Medical Device industry: 5 years
Bachelor's
Regulatory Associate
Summary: Individual will be responsible for coordinating, preparing, and submitting premarket submissions, primarily 510(k)s, to the FDA, technical documentation to the designated notified body, and license applications to Health Canada. Also, acting as a liaison with the FDA, the notified body, and Health Canada before and during the submission review. Reviewing and documenting all changes to cleared products. Interact with functional groups across the organization in the development of relevant data to complete regulatory submissions.
Please submit resume with salary requirements. No phone calls will be accepted.
Regulatory: 2 years
Medical Devices: 2 years
FDA: 1 year
Job Type: Full-time
Bachelor's
RAC Certification
Quality Engineer
Summary: The Quality Engineer (QE I) is responsible for supporting the business processes and operations. Support will include, but is not limited to, tactical input and guidance with respect to Quality functions, as required to ensure the quality of the product and services throughout the enterprise. The QE I is also responsible for leading and/or supporting the continuous improvement activities through the business, quality and regulatory compliance activities in support of new product introductions and modifications to existing products, and supporting quality and regulatory issues to assure compliance with required standards and regulations as well as Company strategies and directives. This QE I role will be require a mix of A) working with cross functional teams, across all levels, in the CER to audit compliance to current MPs and then working with MEs to develop and document improves processes; B) bench/lab work performing testing and subsequent data analysis and C) critical thinking/writing skills for test protocol/reports.
BS degree in Science, Engineering, Materials or Mathematics preferred from an accredited college or university.
Advanced degree a plus.
Six Sigma and Lean training and/or experience is a plus.
ASQ Certification is a plus.
MS Office Applications, Power Point, SharePoint, PowerLink, MAPICS, MS Project.
Certifications, Licenses, Registrations.
Current Passport - for travel to Mexico facility as required.
Prefer Lean Manufacturing and Six Sigma Green Belt.
Complaint investigation, validation support, development of inspection plans, failure analysis, testing, gauging, vendor management issues, and statistical process control.
Work with management on quality planning (both long and short term) supporting diagnosis of quality problems ( both internal and external), corrective and preventative action programs and continuous improvement programs.
New Product and Development Process, Design Reviews and all aspects of Design Control, including, but limited to Quality Planning, FMEA, Control Pans, Hazard Analysis, Biocompatibility, sterilization, and packaging/shelf life studies activities.
Define deliverable quality requirements as input to project plans Material Review Board (MRB) process (Purchased materials and in-house manufactured product).
Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems and to improve vendor quality.
Prepare Vendor QA/Inspection protocols.
Utilize standard statistical analysis techniques to determine product specifications. Participate in vendor site audits and work with suppliers to improve quality of both delivered parts and internal quality processes.
Develop, validate, document and refine QA Test and Inspection procedures.
Select and acquire equipment /tooling as required.
Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
Develop Process Validation Master Plans and IQ, OQ, PQ, PPQ Protocols.
Define sampling plans with statistical rationales, process control plans, and apply SPC to mfg applications.
Monitor and lead improvements based on the evaluation of results.
Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA engineering areas of expertise and lean tools.
Provides direction in the completion of projects by displaying excellent interpersonal skills and completing projects according to specified time lines.
Support Company Strategies as required.
Travel as required to perform the objectives and end results of this function.
Perform other related duties as may be reasonably assigned in the course of business.
Shipper/Receiver
Summary: Medcomp is in search of a dependable dedicated Shipping/Receiving Clerk for our growing medical device company.
Qualified candidates must possess 2+ years experience in a warehouse environment using pallet jack and/or fork lift (certification is preferred). Candidates must possess a valid Driver's License and have the ability to lift 50+ pounds and able to load and unload freight from trucks. Attention to detail and ability to follow instructions is critical. Knowledge of AS/400 or PowerLink is a plus. Experience and/or knowledge of International shipping requirements is a plus.
General duties consist of packaging, shipping, receiving, inventory processing, stocking, & driving/deliveries.
Please send hourly wage rate requirements with resume. No phone calls will be accepted.
Job Type: Full-time
Shipping and Receiving: 2 years
High school or equivalent
Valid Driver's License
Forecast Analyst
Summary: This position will be responsible to create a forecasting model that meets the requirements of the company. Be able to identify, track, and examine product trends in the market. Research sales history to determine market need and determine future demand. Monitor forecasts and determine their effect on Supply Chain activities.
Bachelor's Degree in Supply Chain Management, Statistics or related discipline, 5+ years related experience and/or training; or equivalent combination of education and experience.
Proficient in research, data analysis, statistics and mathematics.
Inventory, Forecasting, and Planning experience is preferred.
Strong knowledge of ISO 13485 is preferred.
Detail oriented.
Problem-solving aptitude.
Excellent communication skills.
Outstanding organizational ability.
Must be a team-player and able to work on cross-functional teams.
Please submit salary requirements with resume.
No phone call inquiries will be accepted.
No Sponsorship is available for this position.