QC Specialist – Medical Device

Philadelphia, PA

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Position Summary:

Seeking an experienced quality professional that specializes in Regulatory Compliance, specifically to FDA medical device guidelines, ISO9001/13485, EU MDR and 21CFR820 codes. The primary responsibility of the position is to monitor and review industry standards while helping maintain a quality program that strives for continuous improvement.

Primary Responsibilities:

  • Maintain continued awareness of emerging reporting requirements (worldwide).
  • Develop, implement, and maintain all aspects of an effective quality management system that meets the requirements of the FDA QSRs, 21 CFR PART 820, ISO 9001, ISO 13485, the EU MDR, and other applicable standards as identified for commercialization of medical devices.
  • Responsible for regulatory and quality aspects related to design, development, manufacturing, registration, and commercialization of medical device products. This position will work in a team environment, interacting with all departments, Engineering, Operations and Marketing.
  • Coordinate and prepare all US and International regulatory submissions, including coordination with regulatory agencies for any pre-submission strategies, as necessary.
  • Participate in regulatory/customer audits.
  • Perform on-site supplier audits when necessary.
  • Assesses customer complaints for potential regulatory reporting, based on product specific criteria. He /she verifies assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling.
  • Working as part of a cross-functional team, ensure that products are designed, developed, and manufactured in accordance with internal procedures and meet the requirements set forth in the applicable regulations and standards including performance testing requirements.
  • Develop and implement with Engineering & Marketing the corporate regulatory strategies for new products and marketed products based on US, EU and other International standards, regulations, legislations, and guidance.
  • Develop and monitor supplier performance program according to company policies, including on boarding new suppliers and managing current suppliers, audit according to supplier quality agreements.
  • Implement company feedback and monitoring and measuring programs with quality team (e.g. CAPA, NCR, Complaints, Internal Audits) according to company policies and regulatory requirements, ensuring reportability and field action assessments are made and reported appropriately including regulatory authority reporting.

Qualifications/Skills/Experience:

Depending on experience, the Specialist will have a working knowledge of medical device quality management system regulations and guidance. The individual should have some experience in best QMS practices with a view to end-user satisfaction and international regulatory expectations.

Requirements:

  • BA/BS required.
  • ASQ Certifications preferred.
  • Minimum 3-5 years of compliance-focused education and/or experience working within medical device manufacturing quality management systems.
  • Strong familiarity with 21 CFR Part 820, ISO 13485, and EU MDR.
  • Experience in quality assurance processes (root cause, risk assessment, CAPA).
  • SME in FDA, ISO, EEO Regulations
  • Reliable self-motivated, leadership, and training skills.
  • Strong communication skills – both written and verbal.

Job Details

Seniority Level
Entry-level

Industry
Medical Devices

Employment Type
Full-time

Job Functions
Quality Assurance

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The New Nanoject III Is Now Available!

Nanoject II vs. Nanoject III Comparison

Both units utilize the same glass capillaries for pulling micropipettes. Due to the new improved method of securing the micropipette, smaller tips can be pulled and utilized on the Nanoject III. No O-rings to wear out. A micro “chuck” is used, and it simplifies attachment of the micropipette once backfilled with oil. The Nanoject III’s auto HOMING feature will eliminate the need to “rehome the unit as in the Nanoject II. This can reduce, if not totally eliminate, jamming of the plunger. Now available for the Nanoject II is the new Digital Control Box which has all the functionality of the original control box but now features a user friendly, easy to read touchscreen.

Product Name Nanoject II Nanoject III
Injection volumes 2.3 nL-69 nL 0.6 nL-999.9 nL
Rate of injection 46 nL/sec.& 23 nL/sec. only 1 nL/sec.-200 nL/sec.
Injection counter No Yes
Programmable multiple injections No Yes
Programmable frequency between injections No Yes
Auto HOMING of plunger No Yes
Micropipette I.D. size 10 µm minimum 2-3 µm minimum
Optional Footswitch Yes; inject only Yes; fill, empty and inject capability
Color, Touch Sensitive Keypad No; fill, empty, inject buttons only. Optional Digital Control Box Upgrade available Yes; multi screens
External computer interface Use of footswitch contact to inject. Injector has to be finished its injection at the speed rate of the Nanoject II before it will accept another pulse Use of a special opto-isolated input to allow the user to control injection rate and injection volume

Drummond Pipet-Aid® Controller Comparison Chart

Use this comparison chart to understand the difference between Drummond Pipet-Aid® Controller models and their useful features. This information will help you choose the best pipette controller to deliver the most accurate results for your intended applications.

Feature Other Pipette Controllers Portable Pipet- Aid® XP Pipette Controller Portable Pipet- Aid® XL Pipette Controller Pipet- Aid® Hood Mate® Pipette Controller
Cordless/Portable
3 Speed Aspiration & Dispensing X
Removable Stand X X
Use in hood/laminar flow cabinet X X
Weight 230g 214g 214g 122g