Operations Manager

September 8, 2023

Position Summary:

The Operations Manager is a dynamic, challenging, and high-impact role that reports directly to senior leadership. Integral to all aspects of the business, the Operations Manager contributes to project teams, and manages production planning and resource allocations, along with tracking key performance indicators (KPIs) for production.

Essential Duties and Responsibilities:

• • Ensures compliance to ISO 13485 and 21 CFR 820
  • Develops assembly processes and product inspection or test processes, including custom fixtures/tooling/gauges.
  • Manages and executes process validations
  • Contributes to Risk Management efforts including Process Failure Mode and Effect Analysis
  • Supports New Product Introduction (NPI) and Design Transfer activities
  • Assists with build planning and inventory management
  • Ensures the accuracy and completeness of documents and records for inclusion in DHFs / DHRs
  • Collaborates on compliant and efficient strategies for reaching customer milestones
  • Participates in Material Review Board activities and dispositions nonconforming inventory
  • Leads root cause investigations and participates in the CAPA process
  • Tracks KPIs and reports performance to management
  • Provides mentorship and leadership to other manufacturing and operations personnel
  • Establishes personnel development plans
  • Measures performance and holds formal reviews with direct reports

Required Education, Experience, Skills, and Knowledge:

• • Minimum 7 years of professional experience
  • Medical Device experience required
  • Production support experience required
  • Product development or NPI experience required
  • Bachelor’s Degree in Engineering or Technical Field required
  • Prior leadership experience preferred
  • Well versed in ISO 13485 and 21 CFR 820
  • Strong understanding of statistical methods and sampling plans
  • Excellent aptitude and confidence in customer facing communications
  • Detail oriented, organized, and diligent in record keeping and Good Documentation Practices (GDP)
  • Willing to learn and grow within the organization
  • Customer focused with excellent communications skills, written and oral

Salary Range:

$93,000 to $139,000 (25th percentile/90th percentile, PayScale data); Bonus eligible depending on achieving company performance targets.

Benefits:

This position will be eligible to enroll in benefits including health, dental and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k). Position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).

Apply to: humanresources@meddux.com