Owens & Minor Quality Control Lead in Louisville, Kentucky
Leads the Quality Control Inspection team ensuring that training is completed, priorities are assigned and work is completed in a timely and accurate manner. Performs technical inspections of medical devices / instruments/pharmaceuticals for acceptance and report any non-conformance to the Director of Regulatory . Completes accurate and detailed record-keeping activities for inspection results and dispositions. Maintains current documentation used for inspection activities. Assists in handling non-conforming VAS (VMueller) Quality Control issues that impact the 3PL business unit, including Federal, state, and local regulatory issues, training and development, product compliance, special handling regulations, and related information technology requirements. Ensures compliance to Calibration system. Reports to Director, Regulatory & Compliance.
ESSENTIAL JOB FUNCTIONS:
- Ensures facility Quality Systems are maintained in compliance with cGMP, ISO9001 2008, ISO 13485, and 21 CFR part 11, part 7- subpart C (Recalls), and part 820 (Quality System Regulation).
- Ensures products released and distributed adhere to Quality System policies and procedures and within client and Regulatory requirements.
- Leads team in the completion of, and participates in, the following duties as defined by SOPs, WIs, drawings, and specifications:
i.Inspects medical devices / instruments (i.e., Receiving, In-Process, Finished Product) using mechanical inspection equipment, such as Calipers, micrometers, optical comparators, hardness testers, etc.
ii.Escalates non-acceptable inspection results to Director, Regulatory & Compliance , for remediation.
iii. Maintains current versions of SOPs, WIs, drawings, and specifications related to all inspection activities.
iv.Maintains records of inspection results and dispositions, audits the records of the QC Inspector and VAS packaging.
Monitors instrument device calibration schedule to ensure maintenance frequency and measurement accuracy. Provides direction and assignments to the OM HCL QC Technician/Inspectors.
Serves as the key interface to Client quality in communicating status of inspections, holds and required to attend and participate in client MRB/NCMR telecom meetings. Coordinates rework as directed by client of Medical Devices and/or Pharmaceuticals.
Controls all change notifications from Client to product specifications, documents, and labeling.
Ensures that IFU (Instructions for Use) are inspected, reviewed and approved, and that operations are using the correct revision.
Performs technical detailed inspections on First of Code products.
Answers technical packaging/labeling/quality questions for internal OM HCL operations, contacts Client Quality groups for verification of information when data available is unclear.Provides training to the QC Inspector and to VAS packaging teammates.Provides priority assignments to QC Inspectors, assuring that they have the necessary training to do the assigned inspection.
Establishes and maintains operational suitability of inspection and designated quarantine areas.
- Creates monthly inspection metrics.
SUPPLEMENTAL JOB FUNCTIONS:
Participates, as required, in the following activities:
CAPAs, Internal Audits, or external supplier audit
- Drafting SOPs, WIs, and forms for uploading into SmartDoc
- Investigation and resolution of non- conforming products
- Product training
- Performs additional duties as directed.
EDUCATION & FORMAL TRAINING:
High School diploma or GED required;Four-year undergraduate degree preferred.
At least 4 years of experience conducting mechanical / technical inspections in the Medical Device or Pharmaceutical Industry.Experience with reusable medical devices and stainless steel processing experience a plus. Must have had experience in a GP environment.
KNOWLEDGE, SKILLS, AND ABILITIES:
1.Working knowledge of regulations (ISO, FDA (210,211, 820), standards, current industry practices, and cGMP regulated environment
2.Able to read and interpret blueprints, SOPs, and WIs
3.Proficient with technical inspection instruments and tools to appraise product
4.Healthcare industry experience required
5.International regulatory experience / exposure a plus
6.Excellent written and verbal communication skills with proven ability topresent and facilitate in meetings
7.Demonstrated very strong problem solving skills
8.Flexibility with an ability to lead others and work as part of a tea
9.Customer first focus
10.Outstanding communications skills - both oral and written
EQUIPMENT, TOOLS AND WORK AIDS:
Proficient with Microsoft software (i.e., MS-Word, MS-Excel, MS-Outlook) required
Proficient with Pilgrim software (e.g., SmartDoc, SmartCAPA, etc.) a plus
Proficient with Red Prairie software a plus
Knowledgeable of general office equipment, to include PC
WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS:
1.Inside working conditions.
2.No environmental hazards indicated for this classification.
3.Up to 5% travel.
Sedentary Work: Exerting up to 50 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
TYPE OF PHYSICAL REQUIREMENTS:
Clarity of vision at 20 inches or less.
Adjustment of lens of eye to bring an object into sharp focus. This item is especially important when doing near‑point work at varying distances from eye.
Extending hand(s) and arm(s) in any direction.
Picking, pinching, or otherwise working with fingers primarily (rather than with whole hand or arm as in handling).
Expressing or exchanging ideas by means of the spoken word. Talking is important for those activities in which employees must impart oral information to clients or to the public, and in those activities in which they must convey detailed or important spoken instructions to other employees accurately, loudly, or quickly.
Perceiving the nature of sounds. Hearing is important for those activities that require ability to receive detailed information through oral communication, and to make fine discriminations in sound, such as when making fine adjustments on running engines.