- Teleflex (Chelmsford, MA)
- …supporting manufacturing, preferably medical devices. * Experience with FDA QSR process and validation documentation requirements a plus. **Specialized Skills ... / Other Requirements** * Experience with IQ/OQ/PQ and P/DFMEA * Experience with Injection molding equipment and processes (especially in Medical Devices) * Experience with Resins and other Polymers used in Injection Molding * Experience with Tooling used in… more
- J&J Family of Companies (Santa Clara, CA)
- …the medical device industry is strongly preferred + Knowledge of cGMP, FDA 820 QSR , ISO 13485, or other Quality Systems + Strong technical writing skills + Effective ... communication skills across all levels of the organization + Must be proactive, self-motivated, and able to work independently with minimal supervision + Ability to work independently in a fast-paced environment while managing multiple priorities + Knowledge… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR 's (21 CFR Part 820) **Required Knowledge and Skills** + Experienced ... in project management. + Organizational / motivational skills. + Capable of managing a range of projects and activities in parallel. + The ability to manage by influence in addition to functional responsibility. + The preparation, planning and presentation of… more
- 7-Eleven (Irving, TX)
- …in Microsoft PowerPoint, Excel and other Microsoft Office applications + Previous QSR , Retail or Franchisee experience a plus EDUCATION AND EXPERIENCE: EDUCATION: ... Bachelors/4-year degree (public relations, communications, journalism, or business preferred) YEARS OF RELEVANT WORK EXPERIENCE: 10+ years YEARS OF MANAGEMENT EXPERIENCE: 2-3 years If an hourly or salary range is included in this ad it represents the range… more
- Abbott (Alameda, CA)
- …in a regulated environment. + Knowledge of FDA Quality System Regulations ( QSR ) and ISO 13485 standards. **Preferred Qualifications** + Strong ability to manage ... multiple tasks and priorities in a fast-paced, changing environment. + Advanced proficiency with Microsoft Office; experience with SQL is a plus. + Strong analytical skills with the ability to query, refine, and summarize data. + Excellent communication… more
- ManpowerGroup (Des Plaines, IL)
- …System. + Create and process electronic Quality testing documents in compliance with QSR , ISO 13485, and other standards. + Initiate and verify Document Change ... Requests (DCRs) for accuracy and compliance. + Support project teams to improve testing and document efficiency. + Prepare Quality testing documents for new products and on-market updates. + Assist in issue resolution and provide recommendations to management.… more
- Markem-Imaje (Salem, NH)
- …+ Statistical sampling and quality control methods + Design of experiments + CGMP's, QSR 's, ISO, TS (auto), AS (Areospace), FDA (food and Drug) and TQMS quality ... systems. + Risk Management and Hazard Analysis techniques + Data analysis + Quality by Design (QBD ICHQ10) + FMEA ASTM:J1739 + IQ, OQ,PQ and PV plans + Excellent written and verbal communication, presentation and interpersonal skills + Ability to effectively… more
- BD (Becton, Dickinson and Company) (Woburn, MA)
- …in production when needed. + Thorough understanding of industry regulations including cGMP, FDA/ QSR , and ISO environment for Class III Med devices or equivalent + ... May also perform and document process non-conformance investigations, identify root cause, and participate in corrective and preventative action efforts + Support in activities such as non-conforming product and complaint investigations, design of experiments,… more
- Imperative Care (Campbell, CA)
- …quality systems designed to meet governmental regulations such as FDA, GMPs, QSR , ISO 13485/9001, and the MDD. + Experience leading a technical cross-functional ... team through all phases of product development. Strong understanding of braiding, laminating, coiling, and laser cutting design and process constraints. + Ability to be self-directed with minimal direction and supervision and take initiative to discern from… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral ... standards highly desired **Desired Qualifications:** + Graduate degree (MS or PhD) in Mechanical Engineering, Biomedical Engineering or related field + 8+ years of post-educational experience in Medical Device Design highly desired + 4+ years of experience… more