Job Information
Tecomet SENIOR QUALITY MANAGER in Warsaw, Indiana
Build innovative solutions and design the future .
You can pursue your potential at Tecomet by working with a dedicated team to solve complex challenges, in partnership with industry-leading clients in medical device technology, aerospace, and defense industries. With the backing of our steadfast brand, you can be a part of the next era of manufacturing by bringing bold ideas to life and building products that improve on the status quo.
What’s In It For You:
At Tecomet , we believe that everyone makes a difference and contributes to our overall success. We are a team bound together by pride in our work and dedication to our craft. Our leadership team shares the company’s strategic direction so our workforce can remain informed and attain our internal goals and objectives.
Let’s talk about what we have to offer:
Competitive pay and benefit packages
Health Benefits start on day one
401k available with matching
9 paid Holidays with 2 Floating Holidays
PTO offered
POSITION SUMMARY:
The Sr. Quality Manager provides overall company leadership and direction to meet customer quality requirements, create, monitor, and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining Tecomet’s principles of Safety, Quality and Customer Satisfaction.
ESSENTIAL FUNCTIONS:
Promote and develop plans with Tecomet’s customers to certify Tecomet as a preferred supplier.
Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs.
Optimize manufacturing process run time by identifying and eliminating production failures. Participate in Material Review Board process.
Coach and train Quality Engineers and Quality Inspectors.
Internal & external audits/supplier approvals.
Develop global Quality and Manufacturing standard operating procedures and related improvement plans.
Measure the effectiveness of the systems in place, report back to upper management and develop. assessments and corrective action plans.
Oversee/facilitate Design and Development quality & regulatory requirements, which encompass all of design control, Medical Device Listings with the FDA and other affected international governments, vigilance/medical device reporting, Declarations of Conformity.
Oversee special processes validations and gage control.
Device pre-sterile packaging and sterilization requirements.
Records retention/archives management.
Project a positive and professional image of the company and of management to employees at all levels.
Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential, and positive manner while abiding by all laws, policies and procedures.
Additional functions and requirements may be assigned by manager as deemed appropriate.
Responsible for timely performance reviews.
KNOWLEDGE, SKILLS, AND ABILITIES:
Strong background in the medical device industry.
Possesses strong knowledge in manufacturing operations.
Knowledge of and Responsible for the quality standards within the company.
Lean manufacturing.
Promotes 5S within his department and throughout the company.
Supports the customer focused team environment.
Knowledge of Tecomet’s business systems and the impact on business.
Possesses knowledge of all applicable domestic and international medical device industry requirements.
Ability to apply advanced mathematical concepts and apply mathematical operations to determine such tasks as test reliability and validity, correlation techniques and factor analysis.
Ability to read, analyze, and interpret complex documents such as financial, quality and production reports.
Ability to respond effectively to sensitive inquiries or complaints.
Ability to multi-task and prioritize work.
Is able to communicate at all levels of the organization.
Is flexible and is able to adapt to changes in the marketplace.
Create and manage high performing work teams.
Identify and make process improvements.
Interface professionally and courteously with customers/public/internal staff.
Meet goals and objectives set for department and company.
Keep current in changing work methods and regulatory changes.
Make decisions in a consistent, professional manner.
Maximize opportunities for the business.
EDUCATION AND WORK EXPERIENCE:
Bachelor’s degree (B.A.) from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience.
3 years manufacturing experience.
PHYSICAL AND ENVIRONMENTAL DEMANDS:
Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
Ability to maneuver throughout the facility/facilities as needed.
Manual dexterity sufficient to reach/handle items and work with fingers.
Ability to wear proper PPE.
TRAVEL REQUIREMENTS: X YES NO
** Moderate overnight travel up to 10%