Senior Quality Manager

Join Intricon, a growing company with meaningful career opportunities. Intricon is a leading contract development manufacturer in micromedical. For four decades, Intricon has been bringing the world’s smallest, smartest bioelectronic devices to life. We specialize in Microelectronics for Biosensors, Electromagnetic Sensors for Surgical Navigation, and Precision Miniature Molding.

Intricon’s mission is to improve and extend people’s lives by developing and manufacturing micro-medical devices. Our culture is centered on our core values of collaboration, innovation, inclusiveness, velocity, and authenticity.

We are seeking a dynamic Senior Quality Manager. In this role the Senior Quality Manager will lead a team of Quality Assurance Engineers to partner with Operations and Development to ensure Intricon’s customer products are developed, validated and manufactured to meet customer and regulatory requirements.  This role develops, implements, enforces, and maintains policies, procedures, work instructions and control plans to comply with applicable FDA, ISO and other applicable regulatory and medical device standards in support of business objectives. The Senior Quality Manager will also maintain, monitor, and report on established quality metrics and takes necessary actions based on analysis of the metrics.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

1. Oversees and supports product quality through measurement, analysis, and reporting of key quality metrics. *
2. Ensures timely disposition of non-conforming material, implementation of effective corrective and preventive action, and support of Operations through effective management of Quality Engineers. *
3. Ensures Quality Engineers and other QA support team members have efficient and compliant procedures and necessary resources to support Development, Supply Chain and Manufacturing. *
4. Acts as lead Quality representative when interfacing with customers and/or suppliers to address quality issues that impact Intricon Operations or establishing new customer opportunities. *
5. Maintains strong relationships with Manufacturing to achieve departmental and business objectives. *
6. As required, collaborates with Development Teams to ensure qualification plans (IQ, OQ, PQ) and other validation activities are successfully competed to meet specified requirements, performance, and reliability. *
7. Ensure Intricon’s Quality organization remains compliant with applicable regulatory requirements and supports Intricon’s business objectives through effective management of Intricon’s Quality Management System. *
8. Advocate continuous improvement and effectivity of Intricon’s QMS and products. *
9. Lead and manage Quality team direct reports, conducting regular 1:1 meetings, team meetings, and assessing and communicating team member performance reviews. *
10. Other duties as assigned.

*Essential Functions

LEADERSHIP WORKPLACE COMPETENCIES:  

Accountability          Agility          Business Acumen          Communication          Courage    

Cultivate Customer Relationship          Developing People          Embrace Differences

Humility          Problem Solving & Decision-Making          Strategic Leadership          Teamwork

QUALIFICATIONS:  

Education:

• Bachelor of Science degree (preferably in an engineering field) from four-year college or university; or equivalent work experience.
• Master of Science or Master of Business Administration degree preferred.

Experience: 

• Minimum of eight (8) years of experience in quality assurance and quality system compliance in a medical device and/or biotechnology environment.
• Minimum of at least three (3) years of Quality Engineering experience.

Skills:

• Well versed in ISO 13485 and applicable directives and FDA CFR Part 820.
• Effective business acumen to balance compliance and business needs.
• Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
• Excellent communication skills, both written and oral.
• Ability to work independently and collaboratively.
• Solid planning and organization skills including attention to detail, multi-tasking, critical thinking, and problem-solving skills.
• Ability to review and evaluate scientific and technical data and communicate problems and solutions with all levels of technical ability.
• Confidently communicate outside the organization, representing Intricon to customers, the public, Notified Bodies, government, and other external sources.
• Knowledge of MS 365 applications and statistical analysis software (such as Minitab).

Physical Requirements:

• Employee is regularly required to use hands to finger, handle, or feel. Employee is frequently required to stand, walk, sit, talk, and hear. Employee is occasionally required to reach with hands and arms. Occasionally may need to life more than 20 pounds.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

All positions are responsible for following applicable company policies and procedures as defined by their manager.

WHY WORK AT INTRICON?

We are proud to offer competitive compensation and benefits that include:

• Medical insurance
• Health Savings Account – EMPLOYER CONTRIBUTIONS!
• Flexible Spending Accounts
• Dental Insurance
• Vision Insurance
• Life Insurance – COMPANY PAID!
• Accident, Critical Illness, Hospital Indemnity Insurance
• Salary Continuance – COMPANY PAID!
• Long Term Disability – COMPANY PAID!
• 401k – COMPANY MATCH!

Additional Benefits:

• Bonus - based on company and individual performance
• Professional Development and Degree Reimbursement
• Paid Time Off
• Employee Assistance Program / Travel Assistance
• Referral Program
  
  

SALARY RANGE:

The anticipated base pay for this position is: $145,000 - $165,000

Intricon is committed to providing competitive total compensation and benefits packages. This listed range is based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, education, geographic locations, market conditions and internal equity.

Salary : $145,000 - $165,000