ASQ - Section 1506, Jacksonville

Please email current opportunities to the Placement Chair at placement_chair@asq1506.org for listing in this section.

Quality Engineering/Management Opportunities

Quality Engineer, Medtronic, (2) positions- Three Point Solutions, Inc. Posted 7/26/2010

Job Description:

Labor Category : Engineering
Job Family : Manufacturing/Engineering
Job Title : Quality Engineer
Job Duties : Creates and delivers presentations throughout the organization,Design of Experiments (DOE) and Statistical Process Control (SPC),Determines manufacturing operation requirements and process parameters ,Develops plans to evaluate process repeatability and stability ,Participates in procedure writing and review ,Performs process and equipment validations ,Provides technical support to other engineers ,Specifies and implements process lay-outs,Supports manufacturing, development, and implementation processes,Utilizes FMEA within process development ,Ensures compliance with GMP's,Generates documentation for engineering protocols and reports

Required:
Education Level:    Undergraduate Degree

The two positions will focus on transfering manufacturing from Jacksonville to a new location (Grand Rapids, MI). Process Validation and manufacuting line setup while being compliant to FDA. GMPs will be a job requirement. Candidates from Medical Device industry would be ideal. This is a contract position set to start as soon as the best candidates are available and may go as long as 1 1/2 years.

Thank you,

Mary L. Johnson
Sr. Recruiter/Account Executive
Three Point Solutions, Inc.
8033 US Hwy 169 N #8
P.O. Box 372
Garrison, MN 56450

Direct - 320-692-9944
Fax - 320-692-9947
Mary@3ptsolutions.com
www.3ptsolutions.com <http://www.3ptsolutions.com/>
For a complete list of openings, go to www.3ptsolutions.com <http://www.3ptsolutions.com/>

Regulatory Affair Specialist- System Staffing Group. Posted 7/15/2010

Job Description: Reviews, analyzes and evaluates worldwide regulatory registration requirements for new contact lens products. Coordinates global registration activities including preparation of submission documents in support of 510(k)’s, PMA/Supplements and Annual Reports. Reviews and updates the Technical Files in support of CE Marking of product for the European Union. Analyzes the impact of modifications to manufacturing, product and packaging to registration status of approved product and determines appropriate regulatory action required.

Bachelors Degree - Scientific Discipline (or equivalent).

6 - 8 years of working experience within the Pharmaceutical or Medical Device Regulatory environment and a minimum of 2 years experience in Regulatory Submissions. Strong communication, organizational, negotiation and interpersonal skills. General knowledge, understanding and application of principles, concepts and practices of government regulations. Regulatory or clinical knowledge to maintain legal status of products and minimize risk. Broad based technical knowledge and skills in diverse areas of business (e.g. R&, Operations, QA, laboratories, marketing, etc.). Ability to organize and analyze data and identify issues or gaps. Ability to provide innovative solutions within the boundaries of Regulation.

Proficient use of Microsoft Office Suite including Outlook.

No travel required with the exception of local transportation needed to work between Vision Care campuses.

All work will be done on site.

1. Reviews, analyzes and evaluates global registration requirements. (25%)

2. Assists project teams with identification of data requirements and coordinates the collection of data and documents to meet global registration requirements. (25%)

3. Maintains a current and accurate EC Technical File for the company’s products. Prepares and submits registration documents and periodic reports to FDA and other ministries of health. (20%)

5. Conducts and documents assessments of proposed change requests to determine regulatory impact. (20%)

6. Performs other related duties as assigned by management. (10%)

If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please email me ASAP with your updated Word resume and references, even if we have spoken recently about a different position. When replying please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.Thank you.

Robert DeSantis
Systems Staffing Group, Inc.
111 Presidential Blvd, Suite 231
Bala Cynwyd, PA 19004rdesantis@systemsstaffinggroup.com
610-668-8101 (O)610-668-8102 (F)

Following are links that may be of use to the members of Section 1506. If you know of additional links, please email them to the Internet Liaison at internet_liaison@asq1506.org.

Current Opportunities

Quality Engineering/Management Opportunities