Quality Manager - Medical Device Manufacturer

Quality Manager

Focus on innovation & continuous improvement!

Stable and growing Medical Device Manufacturer

Our client, a medical device manufacturer based in the Wheeling area, operates more than 15 locations across the U.S. and employs over 5,000 people. As they continue expanding their product lines, they are seeking a Quality Manager to join their Quality team. Serving well-known OEMs such as Stryker and Medtronic, this role will be responsible for managing customer communications, driving root cause analysis and corrective actions, and leading floor initiatives to improve efficiency.

Job Description

Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.

Leads and implements various product and process improvement methodologies.

Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.

Leads in the completion and maintenance of risk analysis.

Leads generation and completion of protocols and reports for test method validations.

Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.

Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.

Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.

Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.

Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions

Provides support to other quality engineers.

Performs other functions as required.

Please apply below, if you're resume looks to fit in with the criteria. From there, Ben Aldrich from Michael Page will reach out in the next 48 hours if deemed a fit!

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Bachelor's Degree (Engineering-related preferred)

5+ years of management experience in a regulated manufacturing environment, such as medical device, automotive, or aerospace

Experience in a metals and / or machining environment

Project Management and Lean Manufacturing experience

Good knowledge of statistical tools and appropriate use of Design of Experiments (DOE) when developing recommendations

Excellent communication and interpersonal skills

Working knowledge of ISO 9001 : 2015, ISO 13485 : 2015, 21 CFR, and cGMPs

Sponsorship not provided

What's on Offer

Competitive base salary between $120,000-$140,000, depending on experience and skills

Bonus opportunity up to 15%

Comprehensive benefits package including Medical, Dental, and Vision

Medical / Prescription Drug Coverage - 3 Blue Cross Option (2 PPOs, 1 HDHP)

Health Savings Account and Flexible Spending Accounts

Dental Coverage - 2 Met Life Options

Life and AD&D Coverage

Short-term disability coverage

17 PTO Days + 10 holidays

401(k) with 3% company match