Manager, Quality Operations (Finance)

Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Manager of Quality Operations supports Bioventus operations and quality functions by ensuring the Quality team maintains a high level of performance for both in-house and outsourced manufacturing. The person in this role is the quality leader and voice within manufacturing operations and will lead the resolution of quality events related to receiving, production and shipping of products. This role will collaborate with leaders across the organization including Manufacturing, Engineering, R&D and Regulatory to meet department's goals and objectives. Additionally, this role will communicate with external suppliers to resolve quality issues detected during receiving and incoming inspections. As a site quality leader, this role will also support other areas within Quality Assurance and Quality Systems as needed.What you'll be doing

• Leads the Quality Operations and Engineering Quality functions and manages the applicable Quality Management System policies, procedures in compliance with Global Quality System Regulations
• Prepares and supports other quality leaders within the organization for internal and external audits and ensures successful completion, including follow-up activities.
• Manages Quality Engineering team to ensure availability and capability of staff supporting the Manufacturing Operations and Quality Control.
• Supports QA and QC continual improvement efforts including Corrective and Preventive Action (CAPA), Investigations (INV), and complaints.
• Manages development/implementation of quality control training programs for quality function.
• Reviews and approve of engineering and/or regulatory changes to assess their impact on quality systems and address deficiencies.
• Supports supplier management activities like supplier qualifications, risk assessments, audits, and SCARs. Collects, monitor and trends supplier quality data.
• Oversees the non-conforming material process in accordance with local procedures and global requirements/standards.
• Conducts and leads Material Review Board (MRB) to ensure timely disposition of quarantined products. Collects, monitor and trends MRB data to identify continual improvement initiatives.
• Develops, monitors and reports KPI associated with Quality Operations processes.
• Participates as needed and ensures departmental capability to support Design Control and Design Transfer activities.
• Identifies specification needs/requirements & assist with the creation of specifications and inspection processes.
• Supports development of inspection processes, GRR, capability studies and process validation.
• Participates in continuous improvement programs; Works with cross functional teams such as manufacturing, IT, suppliers and R&D to improve the current processes where needed.
• Participates in continuous improvement programs. Works with cross-functional teams such as manufacturing, production and R&D to improve the current process.
• Works with multiple project schedules and manages competing priorities
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Performs other related duties as assigned

What you'll bring to the table

• Bachelor's degree in Science, Engineering or related field or Associate's degree plus 5 years' experience.
• Minimum of 3 years of experience managing personnel and quality assurance/systems processes in regulated environments is required, preferably in the manufacturing of medical device/ combination products or biologics industries.
• Experience with Metrology and Quality control activities is preferred.
• Strong knowledge of SAP is required.
• Superior command of the Microsoft office tools like Word, Excel and Power Point is required
• Certification from American Society for Quality (ASQ) such as Certified Quality Technician (CQT), Certified Quality Engineer (CQE) or Certified Quality Manage (CQM) is desirable.
• Must possess excellent verbal and written communication skills at all levels within the organization
• The following competencies are a must: Ownership & accountability, leadership, responsiveness, initiative, adaptability and continual improvement
• Knowledge of FDA regulations 21 CFR Part 803 & 820 and ISO13485. Knowledge of medical device products and manufacturing processes is a strong plus.

Are you the top talent we are looking for?

Apply now! Hit the "Apply" button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.