Quality Control Manager

Broomall, PA

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Job details

Job Type
Full-time

Qualifications

  • US work authorization (Preferred)

Benefits

Pulled from the full job description
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off

Full Job Description

Duties/Responsibilities:

· Effectively maintain a paper-based Quality Management System

· Conduct regular document reviews to recommend, initiate, implement, and verify solutions for continuous quality and process improvement with the appropriate approval.

· Evaluate and report on the effectiveness and implementation of the quality system.

· Conduct annual risk management reports for Product Realization Activities

· Monitor regulations and standards to ensure prompt responses to any changes

· Coordinate with the VP of Sales & Marketing to ensure effective Supplier Performance Monitoring and Management

· Provide training to personnel performing quality-related activities and maintain the training matrix

· Coordinate with vendors for proper calibration of all monitoring and measuring devices

· Coordinate and supervise internal and external audit activities to verify essential quality characteristics.

· Ensure effective closure of audit activities by working with auditees to ensure comprehension, development, and execution of corrective/preventive action regarding any nonconformities.

· Review inspection results for accuracy and compliance with established requirements.

· Investigate device complaint records and examine returned goods to verify non-conforming conditions and implement corrective actions as appropriate.

· Authority to stop product processing, release, and distribution.

· Participate in and document Management Reviews

· Work daily with the Warehouse & Shipping Coordinator to prepare and ship the final product.  Average of 2 to 3 hours per day with some days each month of 5 to 6 hours.

Required Skills/Abilities:
· Demonstrated understanding of cGMP, ISO 13485: 2016 and IVDR

· Ability to effectively advocate a strategic quality systems approach.

· Ability to work effectively with all departments to ensure conformance to regulatory requirements, internal processes, and policies.

· Strong written and verbal communication skills

· Strong knowledge of Microsoft Office

· Ability to prioritize tasks to meet deadlines

Education/Experience:
· Bachelor’s Degree required

· Experience in maintaining an ISO 13485: 2016 quality management system and training program preferred.

· Internal or external auditing experience in medical devices or other regulated manufacturing environments preferred.

Physical Requirements:
· Must be able to handle packages weighing 50 lbs routinely.  (occasionally more)

· Prolonged periods of sitting and working on a computer

· Prolonged periods of standing

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off

Schedule:

  • 8-hour shift

Supplemental Pay:

  • Bonus pay

COVID-19 considerations:
We are a 100% employee-vaccinated facility.  A Masking policy is in effect currently.

Ability to commute/relocate:

  • Broomall, PA 19008: Reliably commute or planning to relocate before starting Work (Required)

Experience:

  • ISO 13485: 1 year (Preferred)

Work Location: One location

Drummond Scientific Company is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, age physical or mental disability, physical handicap, veteran or military status, sexual orientation, or any other legally-recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Job Details

Seniority Level
Associate

Industry
Medical Devices, Scientific 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.

Nanoject II
Nanoject III
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