Qa Jobs

The RA Project Manager will implement strategies and activities required to obtain regulatory approval for new and revised implantable devices and ensure compliance to all US, EU and Regulatory and QA requirements as well as to corporate policies and procedures regarding submissions and other requirements for market approval of medical devices, applying scientific principles.

Primary Responsibilities
• Participate on product development teams to insure US and EU regulatory requirements are incorporated as part of the development process

• Author submissions and other regulatory documents to obtain approval to bring new or modified products to market including but not limited to 510(k)’s, IDE’s, PMA’s, Technical Files and Design Dossiers

• Review and approve labels, labeling and marketing/sales collateral materials for pre and post - market applications

• Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers

• Address and advise teams on appropriate pathways to market

• Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues

• Interpret existing and/or new regulatory requirements as they relate to company products and procedures.

• Review and approve change requests with regard to US and EU Regulatory requirements

• Prepare and update US product listings and EU registrations

• Communicate any regulatory body correspondence on submissions to the appropriate team(s) and RA management

• Develop, implement and maintain regulatory SOP’s

• Conduct quality and regulatory training

Qualifications
BA/BS in Scientific discipline
- 7 years experience in RA
- RAC certification desired; quality assurance experience a plus
- 510(k), IDE, PMA (original/revision/supplements) preparation experience
- Preparation of EU Technical Files and Design Dossiers Minimum 4-5 years experience in FDA and EU regulated medical device industry
- Working knowledge of FDA and EU Medical Device Regulations
- Direct interaction with FDA reviewers/inspectors

OTHER POSITIONS / LOCATIONS Available

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Job Summary: Responsible for leading the effort to understand customer requirements by qualifying the product/process and translating them into effective process controls. Drive continuous improvement by working closely with Director of QA & Continuous Improvement.

Duties and Responsibilities:

• Lead NBP teams in developing and implementing APQP, PPAP, FMEA, control plans, MSA, SPC, cosmetic requirements, capability studies and other customer requirements.
• Act as liaison between NBP and customers to identify and interpret inspection, test, and control parameters by understanding the customer requirements.
• Oversees and performs when needed, engineering changes, calibration and other quality documentation.
• Assist with organizational continuous improvement efforts – lean manufacturing, 5S, Kaizen and other initiatives under the guidance of Director of QA.
• Train personnel on quality systems, product and processes at various levels of the organization.
• Responsible for the programming and operation of the CMM, when needed.
• Develop fixtures/gages that enhances process control effectiveness.
• Perform product, process and systems audit through internal, external audits or third party audits.
• Serve as a quality auditor when needed.
• Other duties as assigned.

Who is Collections Etc.?

Collections Etc. is one of the fastest growing and highly successful giftware catalog companies. Our unique selection of value priced merchandise and customer focus has propelled the growth of the company by capturing the hearts and loyalty of our customers.

This position will work out of our corporate headquarters in Elk Grove Village, IL.

What will you be doing for us?

You’ll manage our product testing and inspection program.

We offer hundreds of hardline and softline products in areas such as home décor, housewares, garden accessories and a variety of giftware. (To view our items, visit our website at www.CollectionsEtc.com). This position plans and directs the technical activities of our outsourced product testing and inspection program, including statistical sampling inspection and inspection techniques, testing methods, and product acceptance standards. Responsibilities include:

• Independently plans, coordinates, and directs all outsourced vendor/agent/factory/third party testing and inspection activities.
  
• Acts as the Company’s technical expert in product testing and inspections.
  
• Exercises a high degree of skill, broad experience, initiative, and mastery of QA concepts and principles in constantly adapting the testing and inspection program to ever changing industry, product and testing/inspection standards, criteria and techniques.
  
• Plans and directs implementation of a supplier certification program and vendor “Report Card” to ensure compliance with the Company’s requirements.
  
• Independently designs, organizes, and carries out special studies and projects related to testing/inspection programs’ administration resulting in new test methods, policies or organization changes, and in resolving critical problems.
  
• Ensures compliance with established policies and procedures of the Company’s Quality program.
  
• Maintains close coordination with suppliers’ quality control and management representatives and servers as the communication liaison with vendors, agents, factories on outsourced testing and/or inspection issues.
  
• Uses broad experience, diplomacy, and a high degree of skill to arbitrate disputes and to assist Company buyers during disputes or meetings with supplier representatives on quality testing/inspection techniques, product rejections, or returns of defective merchandise.
  
• Provides recommendations to inventory management and merchandising staff relative to disposition of defective merchandise.

What do you need to bring to the table?

• Associate’s or Bachelor’s Degree in one of the engineering, technical, or related science disciplines or equivalent experience.
  
• Basic understanding of Six Sigma, TQM, AQL, or similar quality programs; Six Sigma class work or training preferred.
  
• Minimum of four years of progressively responsible experience in quality assurance field plus a minimum of three years specialized experience in assuring quality of consumer goods.
  
• Must possess and be able to apply knowledge of quality assurance / quality control, methods, principles, and practices, including statistical analysis and sampling; knowledge of statistical sampling plans and a variety of standard test methods such as ASTM, UL, AATCC, etc.
  
• Knowledge and experience in using proven quality principles, techniques, and methods in the areas of hardline and softline testing and inspection.
  
• Computer literate with MS Office, proficiency in Word, Excel; knowledge in Access helpful.
  
• Effective communication, analytical, organizational, and interpersonal skills in a team-oriented setting.

What do you get from us?

• The opportunity to work for a great company
  
• A track record of growth
  
• Competitive Salary + Bonus potential
  
• Friendly, Comfortable, and Productive work environment!

Plus we offer a generous benefits package which includes:

• Medical Insurance
  
• Dental Insurance
  
• Vision Insurance
  
• 401(k) Savings and Investment Plan
  
• Short- and Long-Term Disability coverage
  
• Life Insurance for Self and Dependents
  
• Flexible Spending Accounts
  
• Tuition Reimbursement
  
• Paid Time Off Plan
  
• Onsite Subsidized Cafeteria
  
• Onsite Fitness Center
  
• Employee Discounts AND MORE!!!

For consideration, please email resume and salary history to: Register to View

Equal Opportunity Employer

Life-Tech, Inc
4235 Greenbriar Dr.
Stafford, Texas 77477
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We are currently seeking a QC Analyst II To perform quality control analyses in support of new and established products in compliance with ISO 9001:2000 standards. Primary responsibilities include analytical support of general production and custom synthesis activities through in-process and final release testing.

Essential Functions

• Perform routine quality control final release and in-process testing of established and new materials and products developed and produced at Invitrogen Detection Technologies, in compliance with ISO 9001:2000 standards.
• Perform routine quality control raw material testing and final release testing of OEM and consignment products, in compliance with ISO 9001:2000 standards.
• Analysis of products and research materials include, but is not limited to, the use of the following methods; flow cytometry, spectrophotometric and fluorometric techniques, SDS-polyacrylamide and agarose electropheresis, Western blots, enzyme assays, ELISA, HPLC, and immunofluorescent microscopy.
• Maintain detailed records of testing results, following corporate guidelines for record keeping ensuring regulatory standards. Follow written protocols precisely, noting any deviations that might occur (after supervisor approval).

• Participate in analytical investigations of product troubleshooting, stability monitoring and method validation.
• Develop and maintain quality-testing specifications for use by the laboratory personnel.
• Maintain various instruments and related records within the laboratory. Note variances on standard operating procedures; audit and evaluate process documents and propose revisions.
• Follow and adhere to cGLP's, cGMP's Work Instructions and all safety regulations as they apply to the laboratory and work areas.
• Represent the laboratory during customer audits and on cross-departmental teams.
• May be required to perform other related duties as required and/or assigned and provide guidance to lower level personnel.

Knowledge, Skills and Abilities:

• Knowledge of the theories, practices and procedures of biology or chemistry as normally obtained through a Bachelors degree program in Biochemistry or Molecular Biology, plus five years experience in Quality Control within an industrial setting, or an equivalent combination of education and experience.
• Hands-on experience with flow cytometry methods and method troubleshooting would be highly desirable, as would be the maintenance of flow cytometry instrumentation and associated consumables.
• Good knowledge/skill of data analysis and statistics.
• Good organizational skills and methodologies with the ability to complete multiple tasks quickly and efficiently.
• Ability to follow supervisory direction and correct safety protocols.
• Good verbal and written communication skills and the ability to express scientific results in a clear, concise manner to those from diverse ethnic and cultural backgrounds.
• Good skill with mathematical calculations, particularly relating to those related to analyzing technical/laboratory data.
• Some knowledge of fluorescence and light microscopy and techniques of sample preparation is preferred.
• Demonstrated proficiency of computer applications in an industrial laboratory setting is required.
• Ability to master new skills, methods and equipment.
• Excellent skill as a team player, and the ability to take supervisory direction.
• Ability to meet the The Invitrogen Protocol (Our Guide to Integrity).

Working Conditions:
Work in a laboratory environment. Required to lift up to 40 lbs. May be required to stand for long periods of time while performing duties. Must be able to work safely with chemicals, biologics and hazardous materials. Use of a lab coat and gloves are recommended at all times. Use of safety glasses is required, according to the rules explained during safety training. Occasional travel may be required.

Apply Online
https://invitrogen.recruitmax.com/MAIN/careerportal/Job_Profile.cfm?szOrderID=2621&szReturnToSearch=1&szWordsToHighlight=

We are proud to be an Equal Opportunity Employer committed to hiring a diverse work team