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QA Lab Tech Brunswick

Brunswick, ME, US

Ref. number:  2926

$500 Sign-on Bonus!

LOOKING FOR AN OPPORTUNITY TO LEARN AND GROW?

 

Molnlycke Health Care is a world leading manufacturer of wound care and single-use surgical products. Molnlycke Health Care is one of the most respected professional health care brands in the world, and we are particularly known for our unique, high quality range of products and patented technologies that allow patients to live better lives and help health care professionals efficiently treat more patients with better care.

 

 

The Quality Assurance Technician is responsible for monitoring the quality of manufactured wound care products and ensuring the quality system is operating according to regulatory requirements and ISO standards.

 

Testing and verification of manufactured products, includes ensuring product conformance to specifications by conducting physical testing in a controlled laboratory environment in preparation for sterilization and final release.

 

QMS system operation includes maintaining specific subsystems as assigned by the QA Supervisor such as CAPA, Document Control, Internal Auditing and Supplier Quality. Other duties may include development and implementation of new procedures, standards and specifications as required by the Quality Management System.

 

KEY ACCOUNTABILITIES:

  • Performs physical testing of finished goods in accordance with product specifications and internal sampling plans.
  • Performs incoming raw material inspections to check for compliance with company specifications.
  • Performs validation material testing as required.
  • Performs data mining activities for trend analysis and improvement projects.
  • Tracks instrument calibrations and ensure test equipment is maintained as required by the calibration schedule.
  • Maintains and reviews quality documents for accuracy and compliance with regulatory requirements and ISO standards.
  • Manages the storage and retrieval of retained product samples.
  • Routinely makes observations of production line processes.  Reports non-conforming findings to the supervisor.
  • Monitors changes to standard operating procedures and make recommendations for improvements to those processes.
  • Prepares required product release documents and assists with final product verifications prior to shipment.
  • Interfaces with other departmental staff members to resolve quality system issues and complaints.
  • Conducts internal auditing of quality system processes.
  • Creates/generates standard and ad hoc reports regarding product quality.
  • Supports the effort to implement best practices within job scope; expected to participate in activities designed to improve production, quality, and EHS.
  • Performs other duties as assigned by manager.

 

 

KEY DECISIONS:

 

  • Determines the efficacy of assigned quality subsystem and takes appropriate actions to correct or improve the system.
  • Determines product conformance to specifications.
  • Evaluates procedures for clarity and process flow and makes change recommendations.
  • Determines if incoming raw materials meet internal specifications.

 

 

COMPETENCIES:

 

  • Positive Attitude and works well in teams or independently.
  • Fluent in Microsoft Office software.
  • Effective communication skills, both verbal and written.
  • Excellent organizational skills.
  • Possess strong ability to perform detailed repetitive tasks with precision.
  • Proficient in the use of problem solving tools to analyze, identify root causes and verify effectiveness of corrective actions.

 

 

QUALIFICATIONS AND EXPERIENCE:

 

Preferred Qualifications

  • Minimum 2 years quality related industrial production experience preferred.
  • Minimum 2 years-experience working in an ISO 9001-2008 certified environment preferred..
  • ISO 13485-2003 experience.
  • Knowledge of Lean Six Sigma manufacturing methods.
  • Medical device manufacturing experience.

 

 

ANY OTHER INFORMATION:

 

  • Ability to wear approved respirator.
  • Ability to work standing for extended periods of time.
  • The functional demands of this position require working around or near equipment that may be hazardous to individuals with pacemaker equipment.

 

 

About Mölnlycke

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home.

We specialize in:

  • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
  • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
  • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
    Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customized trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.
     
    Benefits:
    Molnlycke Health Care offers competitive salaries and a comprehensive benefit package including health insurance, dental insurance, short and long-term disability insurance, life insurance, medical and dependent care reimbursement accounts, 401(K) Plan with company match, profit sharing contribution, discretionary annual bonus, holidays and PTO program.
    We are an Equal Opportunity Employer of women, minorities, protected veterans and individuals with disabilities.


Nearest Major Market: Portland Maine