Senior Quality Engineer

YOU’LL GET A CHANCE TO:

Excel in the technical competence required for the role, including:

  • Specification development, CTQ mapping, test method development and validation, process validations and implementation of CCP within the process, using error proofing, process monitoring, SPC.
  • Complaint handling, NC management, Risk and Impact assessment, Root cause investigation and solution development and verification
  • Product test and release planning, change management and audit
  • Critical thinking and technical writing

Quality lead on multi/cross functional teams to achieve milestones and results.

Represents Croom in Customer interactions relating to product process and system quality elements in a professional, constructive, and commercially aware manner.

Ensures that customer product requirements are defined and implemented within the site QMS

Engage with the new product development team to ensure a smooth transition from development to production.

Drives continuous improvement across the board and takes initiatives to make things better every day.

Owns and drives the Safety/Quality/Service/Cost Metric for the VS.

Leads by example and demonstrates to agreed behaviours.

Aligns the goals and objective setting for the VS in collaboration with management

Executes on Lean initiatives bringing everyone else on board.

Is committed to develop, coach, motivate self and team Leads the VS based on influencing skills without having the hierarchy of all team members

Builds relationships with key stakeholders in the company and addresses their needs of communication and information

Ensure full compliance with regulatory requirements.

Ensure Quality and EHS policies and procedures are adhered to at all times.

WHAT WILL HELP YOU SUCCEED:

Required:

Minimum Level 7 Qualification.
On the job training will be provided for the right candidate.
Strong written and oral communication skills.
Experience working with medical device regulations is desirable.
Good computer skills in usage of MS Office Suite
Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 and principles of GMP in the Medical Device Industry.  

Desired:

Strong computer skills.
Internal auditor courses for relevant ISO (desired)

Additional Notes

Tasks and responsibilities will vary with all positions and the scope of each role may not be limited to the contents listed on this job description. The employee’s manager is responsible for communicating any changes deemed necessary to the quality department. It is the employee’s responsibility to adhere to company procedures and GMP in Croom Precision Medical as part of their job description.

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