By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers’ success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

JOB SUMMARY

The QS Supervisor will primarily be responsible for;

• Ensuring compliance to all relevant regulations which includes the maintaining of all quality systems and related documentation.
• Leading the execution and improvement of quality assurance and quality systems activities.
• Supporting company goals and continuous improvement initiatives

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Employees are expected to support the quality concepts inherent in the business philosophies of Integer including a variety of job related tasks which may not be specific to this position profile.

Accountabilities include:

The QS Supervisor is responsible for:

• Leading the preparation and direct all activities for:
  • FDA inspections,
  • ISO 13485 audits
  • Competent Authority audits
  • Customer audits

• Manage the Internal Audit Program
• Manage the CAPA Process
• Manage the complaint process, ensuring complaint activities are performed in a timely manner.
• Assist in complaint and CAPA investigation and root cause analysis, and performance of effectiveness activities.
• Supervision of quality systems personnel including:
  • Document Control, Quality Systems Engineer
  • Maintain Core records for all direct reports and raise issues concerning timekeeping should they occur
  • Carry out a regular 1:1 meeting with reports as well as a mid-year and annual review.
• Ensure that in your absence (or absence of any of your reports) your areas of responsibility provide adequate day to day service. Ensure that other departments know of your arrangements well in advance
• Project meeting attendance as required.
• Work efficiently using own initiative, escalating decisions to the Quality Manager as, when, and only when, necessary.
• Be an active member of the Integer team and work with all employees to develop a world class lean manufacturing system

SKILLS AND KNOWLEDGE:

• Knowledgeable in ISO 13485, US FDA 21 CFR Part 20, Canadian Medical Device and MDR requirements
• Ability to communicate and work with people inside and outside the department.
• Ability to supervise
• Ability to co-ordinate, plan and organise
• Excellent attention to detail and organisation skills.
• Ability to work to deadlines and on own initiative.
• Excellent verbal and written communication skills.
• Working knowledge of Excel and Word.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

• College graduate with Engineering or science degree or equivalent experience.
• Qualified systems lead auditor
• Competent in preparing written communication and correspondence.
• Ability to make verbal presentations and effectively negotiate with regulatory, technical, medical and legal professionals.
• Comprehension of engineering principles adequate to allow participation in New Products Development and field complaint issues.
• 3 -5 years' experience in a Quality role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment

PHYSICAL & MENTAL DEMANDS:

• Work effectively with close tolerances.
• Ability to co-ordinate, plan and organise based on priorities

U.S. Applicants: EOE/AA Disability/Veteran