Quality Engineer Life Science

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

The Life Sciences Engineer will primarily be responsible for all microbiology, sterilization and biocompatibility related activities.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Employees are expected to support the quality concepts inherent in the business philosophies of Integer.

Accountabilities include:

• Prepare and execute sterilization validations and test protocols/reports
• Evaluate impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market.
• Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods and biocompatibility of products.
• Recommend and/or evaluate alternative sterilization methods, facilities, and processes as needed to support manufacturing objectives.
• Provide sterilization and biocompatibility expertise to ensure all products and processes comply with the regulatory standards and customer requirements.
• Provide sterilization expertise during audits of external sterilization suppliers according to a documented audit plan.
• Manage bioburden monitoring, environmental monitoring, cleanroom practices, and bacterial endotoxin testing.
• Train appropriate company personnel on biocompatibility, sterilization, and microbiological methods and processes as needed.
• Ensure documentation related to biocompatibility, sterilization, and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
• Actively support projects from new product introduction (NPI), R&D and changes to existing products which require microbiology, sterilization and/or biocompatibility activities
• Adhere to and ensure the compliance to all company policies, rules, procedures, and housekeeping standards.
• Work efficiently using own initiative, escalating decisions to the Quality and Regulatory Manager as, when, and only when, necessary.
• Makes decisions that are aligned with management objectives regarding work processes, plans and schedules to achieve quality objectives.
• Resolves project issues by working with team members, management, suppliers, etc.
• Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
• Performs other duties assigned as needed

SKILLS AND KNOWLEDGE:

• Strong communication skills (written and verbal).
• Knowledgeable in ISO13485 and FDA 21 CFR Part 820 requirements.
• Statistical knowledge (DOE, SPC, Sample comparison, etc.).
• Computer literate (MiniTab, Word, Excel, etc.).
• Negotiation and strong problem solving skills.
• Ability to communicate and operate effectively with multiple teams.
• Supplier audit skills.
• Ability to train and lead.
• Good technical report writing skills.
• Knowledge/experience in microbiology.
• Knowledge/experience in sterilization and biocompatibility (minimum of at least 3 years experience.
• Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts, reasoning ability.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

• B.S. Degree in Biology, Chemistry, Microbiology, or other related science, or Engineering with chemistry or biology background.
• Minimum of 3 years experience in a microbiology, sterilization and biocompatibility role in the medical device industry.

  PHYSICAL & MENTAL DEMANDS.

  Work effectively with close tolerances in a fast paced demanding environment.

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